US FDA/CDRH: Device and Patient Problem Codes

Device Problem Codes
Patient Problem Codes
Manufacturer Evaluation Method Codes
Manufacturer Evaluation Results Codes
Manufacturer Conclusion Codes

Device Problem Codes

Problem Code	Problem	Definition
1001	AC/DC, failure to run on
1002	Abnormal
1387	Abrasion from instrument/object
1003	Absorption	The uptake of substances into or across tissues; e.g. skin, intestine, and kidney tubules. In radiology, the taking up of energy by matter with which the radiation interacts.
1004	Accessories, incompatible
1512	Accuracy rate
2577	Activation, difficult/delayed
1006	Adaptor, failure of
2524	Advance, failure to
1007	Agglutinate, failure to	The clumping together in suspension of antigen-bearing cells, microorganisms, or particles in the presence of specific antibodies.
2300	Air eliminator, defective	The air eliminator vents and eliminates air from the cardioplegia delivery system during cardiopulmonary bypass.
1008	Air leak(s)
1022	Alarm not visible
1620	Alarm system, failure of check-catheter
1621	Alarm system, failure of gas-leak/loss
1615	Alarm system, failure of message-battery status
1616	Alarm system, failure of message-check electrode
1617	Alarm system, failure of message-leads off
1618	Alarm system, failure of message-service
1010	Alarm, audible
1014	Alarm, defective
1011	Alarm, delayed
1024	Alarm, error of warning
1009	Alarm, failure of arterial pressure
1020	Alarm, failure of fast heart rate
2386	Alarm, failure of high inspiratory pressure
1017	Alarm, failure of low flow
2387	Alarm, failure of low inspiratory pressure
1025	Alarm, failure of warning
1012	Alarm, failure to
1013	Alarm, false
1015	Alarm, intermittent
1016	Alarm, low audible
1021	Alarm, no lead
1019	Alarm, not audible
2286	Algorithms, inconsistent
2522	Align, failure to
1026	Altitude variations
1027	Ambient temperature, changes in	The temperature of the surrounding medium, such as gas or liquid, which comes into contact with the apparatus.
1029	Antenna, failure of
1031	Application problems
2648	Applicator failure
2583	Arcing
2289	Arcing at electrodes
1032	Arcing at paddles
1033	Arm motion, unintended
1036	Artifact	Anything in a graphic record or medical image that is caused by the technique used to produce the record and is not a natural occurrence but merely incidental.
1039	Artificial
1041	Aspiration, excessive	The removal by suction of excess fluid or gas from a body cavity.
1042	Aspiration, incomplete	The removal by suction of excess fluid or gas from a body cavity.
1043	Augmentation, loss of	Loss of size, degree or effect.
1044	Autofill, unable to
1046	Automatic injection system overinfusion
2307	Automatic injection system underinfusion
1734	Automatic injection system, failure to infuse
1045	Automatic injection system, incompatible
1047	Back-up, failure to
1048	Back-up, failure to convert to
1050	Balloon asymmetrical	Lack of proportion; not symmetrical.
1051	Balloon burst
1052	Balloon leak(s)
1053	Balloon mushroomed
2611	Balloon pinhole
1049	Balloon rupture
1054	Battery charger, defective
1055	Battery failure
2584	Battery, low
1057	Battery, premature discharge of
1059	Bend
1060	Bicarbonate	A salt of carbonic acid; an acid carbonate, as sodium bicarbonate.
1062	Biofilm coating
1063	Blank screen
1064	Bleed back	Backflow of blood and/or fluid/solution.
1065	Blockage
2317	Blood contaminated device	Equipment becomes contaminated from blood/fluids coming from the patient, and must be discarded.
2290	Blood gas measurements, erroneous
1746	Blood in tubing
2318	Blood pooling	Unintended collection/stasis of blood in device.
1067	Bolus mechanism failure
1068	Bond, failure to
2297	Bubble detector, failure of	Failure to indicate the presence of bubbles in the extracorporeal circuit during cardiopulmonary bypass.
1070	Bubble(s)
2305	Burn hole(s)
1071	Burned
1073	Burrs, breakage of	A thin, ragged fin left on the edge of a piece of metal by a cutting or punching tool.
1074	Burst
1076	Cable break
2302	Cable, defective
1077	Calcification	A calcified substance or part.
2440	Calibrate, failure to
1078	Calibration error
2672	Cannula Guide Issue, No Description
2674	Cannula Guide, Difficult to Locate
2673	Cannula Guide, Needle Insertion Difficult
1079	Capacitive coupling	Use of a capacitor to transfer energy from one circuit to another.
1081	Capture, failure to	Inability to achieve effective and consistent depolarization of the heart resulting from the electrical stimulus of the pacemaker.
1080	Capture, intermittent	Ineffective and inconsistent depolarization of the heart resulting from the electrical stimulus of the pacemaker.
1082	Carbon absorption	Use of activated carbon to remove a variety of organic chemicals in the water used in hemodialysis.
2319	Cardiac enzyme evaluation, erroneous
2612	Catheter withdrawal interference
1075	Cathode ray tube (CRT) failure
1083	Cautery	The application of a caustic substance, a hot instrument, an electric current or other agent to destroy tissue.
1084	Channeling	Blood leakage around the catheter upon insertion into the patient.
2586	Charge times, delayed
2288	Charge, aborted
1085	Charge, failure to
1086	Charred	To scorch or become scorched.
1087	Chemical reaction
1088	Circuit breaker tripped
1089	Circuit failure
1090	Clean, failure to
1091	Cleaning, inadequate
1092	Clearance
2576	Clips, scissored
1094	Clogged
2609	Close, difficult to
1095	Clumping	The aggregation of particles, such as bacteria, into irregular masses.
1096	Coagulation	To congeal, solidify, thicken, curdle.
1097	Coefficient error	Measurement value associated with dialyzer clearance.
1098	Coiled
1099	Collapse
1100	Collimator design problem
1429	Collision, unintended	Collision occurring with the patient or other room components caused by device failure or unintended system motion.
1101	Colony forming units	A collection or group of bacteria in a culture derived from the increase of an isolated single organism or group of organisms.
2650	Color Variation, Lens
1102	Compatibility
1105	Component(s) falling
1103	Component(s), broken
1104	Component(s), detachment of
1108	Component(s), incompatible
1106	Component(s), overheating of
1107	Component(s), worn
2292	Components, defective
2306	Components, missing
1110	Computer failure
1111	Computer hardware error
1112	Computer software error
1113	Concentrate	Chemicals, either liquid or powder, used to make dialysate in hemodialysis.
1114	Conduct, failure to
1115	Conductivity	Measurement of the ionic concentration of a solution used in dialysis.
1116	Connection error
1371	Connection(s), loose
1117	Connector pin failure
1118	Contact lens, problem with trial set
1120	Contamination
2303	Contamination, bacterial
1121	Continuity, intermittent	Continuous effective contact of all components of an electric circuit to give it high conductance by providing low resistance.
1122	Continuous
1123	Continuous firing	Fire conducted at a normal rate without interruption, for application of adjustment corrections or for other causes.
1124	Continuous mode failure	Continuous failure of one of several alternate conditions or methods of operation.
1126	Control settings incorrect
1127	Cool, failure to
1128	Coolant, contraindicated
1129	Cooling system, failure of
1130	Cooling, inadequate
1131	Corrode
1132	Counterbalance break
1133	Countershock, failure to deliver	A high intensity direct current shock delivered to the heart to interrupt ventricular fibrillation and restore synchronous electrical activity.
1134	Couple, failure to
1135	Crack(s)
1136	Cross connection
1137	Cross reactivity	The degree to which an antibody or antigen participates in cross reactions.
1138	Crush
1139	Cuff degeneration	Chemical and/or material (heart valve or tracheal) deterioration.
2454	Cut(s)
2587	Cut, failure to
1140	Cutoff point	The point at which there is a transition from spiral flow in the housing of a centrifugal fan to a straight line flow in the connected duct.
1141	Cutter-torque-cable twisted or tangled
1142	Cycle, failure to
2284	Damage, internal/external
2582	Date-related problem, not year 2000 (Y2K)
1804	Debris, metal shedding
1144	Declotting
1145	Decoupling	Preventing transfer or feedback of energy from one circuit to another.
1149	Deflation difficulties
1150	Deflation due to capsulotomy
1151	Deflation due to damage from surgical instrument
1152	Deflation due to trauma
1148	Deflation, cause unknown
1153	Degradation	The reduction of a chemical compound to one less complex, as if by splitting off one or more groups.
1155	Deionizer, failure of	Removes cations and anions used in water treatment systems for hemodialysis.
2338	Deliver, failure to
2664	Delivery System Issue, No Description
2339	Delivery, inaccurate
2526	Dent
1157	Deploy, difficult to	Spread out, utilize or arrange.
1158	Deploy, failure to
1159	Deprimed
1161	Design/structure problem
2504	Deterioration of prosthesis
1069	Device breakage
1162	Device energization, unintended
2379	Device failure
1525	Device remains activated
1526	Device remains implanted
2589	Device tipover
2588	Device, defective
1670	Device, incorrect care/use of
1663	Device, inoperable
1527	Device, or device fragments remain in patient
2608	Device, removal of (non-implant)	Removal of medical devices other than implanted devices.
2590	Device/device fragments, unknown location of
1165	Dialysate	That part of a mixture that passes through a dialyzing membrane.
1166	Dialyzer, failure of	The apparatus for performing dialysis; a membrane used in dialysis.
1168	Disassembly
1309	Disc, incomplete opening of
1169	Discharge, failure to
1170	Discolored
1171	Disconnect
2541	Disconnect, failure to
1172	Disengaged
1175	Disinfect, failure to
1176	Disinfection, inadequate/improper
1177	Disintegrate
1178	Dislocated
1179	Dislodged
1180	Displacement
1181	Display misread
1182	Display, erratic
1183	Display, failure to
1184	Display, incorrect
1185	Disposable
2412	Dissatisfaction
1186	Dissection
1187	Distilled water, contaminated
1188	Dome collapse
1189	Dose calculation error
1191	Drift	Slow movement away from the normal or original position.
1192	Dry, failure to
2407	Dull
1193	EKG/ECG analysis, failure to perform
1195	Elective removal
1196	Elective replacement
1198	Electrical failure
2294	Electrical wires, defective
1194	Electro-magnetic interference (EMI)	Interference, generally at radio frequencies, that is generated inside systems, as contrasted to radio-frequency interference coming from sources outside a system.
2345	Electro-magnetic interference (EMI), compatibility/incompatibility
2149	Electro-static discharge
1200	Electrode contact(s), problem with
1201	Electrode(s), degeneration of
1199	Electrode(s), failure of
1202	Electrode(s), fracture of
1203	Electrode(s), migration of
1205	Emergency power failure
1206	Emergency stop button or switch failure
1207	Emergency table stop failure
2505	End of prosthetic life
2555	Endarterectomy suture breakage	Suture breakage related to endarterectomy surgeries. Endarterectomy is the excision of the thickened, atheromatous tunica intima of an artery.
1208	Endoscopic accessory fire or melt
1209	Energy output to patient tissue incorrect
1210	Energy spectrum incorrect
1211	Energy, failure to deliver
1212	Entrapment	Device and/or accessories caught within patient vasculature or tissue.
1213	Enzymatic cleaner, failure to remove
1214	Erosion
2591	Error message given
1215	Error or warning message, failure to produce
2527	Excessive Manipulation
2629	Exit block
2528	Expiration date error
1216	Expiration date exceeded
1217	Explanted
1218	Explode
1219	External fiberoptic break	Coated with glass or plastic fibers having special optical properties.
1221	Extraneous radiofrequency wave transmission
2618	Extrusion, impending
1222	Failsafe design failure
1223	Failure, intermittent
1224	False claim
1226	False output
1228	False readings
1225	False-negative test result	A test result which erroneously excludes an individual from a specific diagnostic or reference group, due particularly to insufficiently exact methods of testing.
1227	False-positive test result	A test result which erroneously assigns an individual to a specific diagnostic or reference group, due particularly to insufficiently exact methods of testing.
1230	Fiberguide incompatibility
1229	Fiberoptic break/separation
1231	Fiberoptic cladding material separation
1093	Fiberoptic cleaver, failure of
2567	Fibrosis
1233	Filling problem
1234	Film cartridge ejection, unintended
1235	Film processing, inadequate
2151	Film processor failure
1236	Filter
1238	Filter break(s)
1237	Filter leak(s)
1242	Filter tear(s)
1243	Filter, assembly
1244	Filter, inadequate
2308	Filtration process, inadequate	Process used in water purification systems in hemodialysis.
1245	Fire	Exothermic oxidation process by which heat, light energy and glowing gas are given out in the form of flames. In order to be self-sustaining a fire requires a continuous source of fuel, oxygen, and heat.
2610	Fire, failure to
2183	Fitting problems
1246	Flaking
1247	Flammable
1249	Flowrate, inaccurate
1248	Flowrate, restricted
1250	Fluid leak(s)
2619	Fluid/volume, increased
1251	Flush, difficult to
1252	Flush, failure to
1253	Fogging
2630	Fold
1254	Fold, difficult to
1255	Fold, failure to
2654	Folding Issue
1257	Footrest break
1256	Footrest detachment
1258	Footswitch failure
1259	Foreign material
1260	Fracture(s) of device/material
1261	Fragmentation
1262	Frayed
2529	Fumes/vapors
1263	Function indicator light(s), failure of
2316	Fungus
2592	Fuse, blown
1264	Gain, inadequate
1265	Gas delivery system failure
1266	Gas output, improper
1267	Gel leakage
1268	Germicide	An agent that kills pathogenic microorganisms.
1269	Glass, shattered
1270	Gradient increase	Rate of change of temperature, pressure, or other variable as a function of distance, time, etc.
1271	Grounding malfunctions
1272	Growth, will not support
1274	Handpiece break
1275	Handpiece detachment
1277	Handrest break
1276	Handrest detachment
2667	Haptic Damaged in Delivery System
2657	Haptic Issue, No Description
2668	Haptic Stuck in Delivery System
1278	Haptic(s), bent	A haptic is a loop or foot of an intraocular lens implant that supports the lens against the iris.
1279	Haptic(s), broken
1280	Haptic(s), detached
1281	Haptic(s), dislocated
1282	Haptic(s), fractured
2658	Haptic, Kinked
2660	Haptic, Missing
2659	Haptic, Stuck to Optic
1283	Head immobilizer failure
1284	Head motion, unintended
1285	Heat
1286	Heat, failure to
1287	Heating, inadequate
1289	Hemofiltration	A device that corrects abnormalities of the blood by bulk convection of solutes and water through a semipermeable membrane.
2649	Hermetic seal, loss of
1290	High flux rate	The rate per unit of area at which water passes through a semi-permeable membrane, such as those used for ultrafiltration or reverse osmosis.
1293	Hole(s)
1294	Hose line occlusion
1295	Hose line rupture
1296	Hose mismatch
1298	Hot oil leak
1299	Hybrid failure
1300	Hydraulic system failure
1301	Hydrogen peroxide sterilization, explosion during	Hydrogen peroxide sterilization is a method of sterilizing soft contact lenses in a peroxide solution.
1919	IUD (intrauterine contraceptive device), removal of
1920	IV catheter pull out
1302	IV pole, detachment of parts from
1303	Ignited
1304	Image display error
1305	Image orientation incorrect
1306	Image resolution poor
1358	Image reversal, left or right
2675	Immediate/early load (prior to four - six month traditional time period)
1291	Impedance, high	The opposition to the flow of an alternating current, which is the vector sum of ohmic resistance plus additional resistance, if any, due to induction, to capacity or to both.
2285	Impedance, low	Impedance is the resistance met by alternating electrical currents passing through a conductor.
2645	Implant Mobility NOS (Not otherwise specified)
2646	Implant breakage or physical damage
2154	Implant extrusion	Thrusting or pushing out; expulsion by force.
2647	Implant overload
2320	Implant, removal of
2321	Implant, repositioning of
2322	Implant, reprogramming of
1307	Imprecision
2507	Incomplete coaptation
1310	Inflation difficulties
2340	Infuse, failure to
2341	Infusion, intermittent
1312	Injector system failure, no infusion
1313	Injector system failure, overinfusion of
1314	Injector system failure, underinfusion of
1581	Input signal, failure to read
1316	Insertion difficulties
1317	Installation error
1318	Instructions, inadequate
1319	Instructions, incorrect
1320	Insulation degradation	Loss of continuity of insulation via wear, split, crack and/or breach.
1323	Insulation failure
1321	Insulation, detached
1322	Insulation, discolored
1325	Insulation, hole(s) in
1326	Insulation, none
2680	Intended use for traditional use
2679	Intended use for transitional use
2678	Intended use of immediate/early load
1327	Interference
1328	Interference with monitoring device	See also: Electro-magnetic interference (EMI) codes.
1329	Interference with pacemaker	See also: Electro-magnetic interference (EMI) codes.
2157	Interlock(s), failure of
1330	Interlumen communication	Two or more lumens intercrossed.
2383	Internal fixation, revision of
1331	Interrogate, difficult to	To give or send out a signal to a transponder or computer for triggering an appropriate response.
1332	Interrogate, failure to
1334	Intra-cavity procedure, fiberoptic break or fragmentation during
1335	Intraprocedure, fire or flash during
1336	Invagination	The ensheathing, infolding or insertion of a structure within itself or another.
1337	Irrigate, inability to
1338	Kinetic	Relating to motion or movement.
1339	Kink
1340	Knot
2531	Labeling, missing
2381	Laparoscopic sterilization
1342	Laser nozzle separation
1343	Laser output above specifications
1344	Laser output, unintended
1345	Laser pulse timing error
1346	Laser tip separation
2622	Lead tip breakage at implant, fragments remain in ventricle
1347	Lead(s), breakage of
1348	Lead(s), burn(s) from
1349	Lead(s), electrocution from
1350	Lead(s), fracture of
1351	Lead(s), shock from
1352	Leaflet disc escape	Leakage of blood around leaflet disc.
2568	Leaflet disruption due to suture abrasion
2540	Leaflet disruption, cause unknown
2413	Leaflet fracture
1354	Leak(s)
1355	Leak(s) from hydraulic bed system
1457	Leak(s), perivalvular	The escape of blood around a heart valve, particularly around its leaflets.
1357	Leak, radiation
2635	Lens (IOL), defective, problem not specified
1934	Lens (IOL), dislocated intraocular
2631	Lens (IOL), line, crease on
1935	Lens (IOL), migration of intraocular
2632	Lens (IOL), nicked, chipped
2633	Lens (IOL), scratch, mark on
2634	Lens (IOL), torn, split, cracked
2665	Lens Damaged in Delivery System
2651	Lens Issue, No Description
2666	Lens Stuck in Delivery System
2158	Lens aberration, distortion of	Unequal refraction or focalization of light rays by a lens, resulting in degradation of the image they produce.
2384	Lens implant
2184	Lens replacement
1367	Lens washers, failure of
2652	Lens, Stuck to Itself
1040	Lens, aspherical	A lens in which one or both surfaces are not spherical, so designed to minimize certain optical aberrations.
1061	Lens, bifocal	Lens having two portions of different focal power.
1359	Lens, cloudy
2638	Lens, damaged by cartridge
1360	Lens, decentration of
1232	Lens, deposits on
2644	Lens, difficulty loading into cartridge
1361	Lens, disc
1362	Lens, discoloration of
1363	Lens, malposition of
1411	Lens, multifocal	A lens with various dioptric powers, such as bifocal, trifocal or a progressive lens.
1364	Lens, opacification of	The development of opacity as of the cornea or lens.
1365	Lens, repositioning of
2637	Lens, stuck in cartridge
1640	Lens, toric	Lens with a cylindrical component; used for correcting an eye's astigmatic refractive error.
1366	Lens, vaulting
1368	Linear
2593	Locking mechanism failure
1369	Lockout mechanism failure
1370	Looping
1372	Loose
1373	Lubrication
1375	Magnet failure
1376	Magnet mode discrepancy	Alternation in the activation of a pulse generator reed switch by a magnet.
1377	Magnet quench, unintended	Any type of interference that reduces the intensity of fluorescence.
1378	Magnetic interference
1379	Maintain, failure to
2409	Malfunction
2616	Malposition
1381	Markings unclear
1382	Markings, none
1005	Measurements, inaccurate
1383	Measurements, incorrect
1384	Mechanical failure
1385	Melts
1390	Membrane leak(s)
1391	Membrane tear(s)
1392	Meter
2382	Meter failure
1393	Method, improper/incorrect
1395	Migration
1374	Milliamps (MA) rate, unable to increase	A milliamps is a measurement of the flow of electricity.
1396	Mineralization
1397	Misapplication
1398	Misassembly
2410	Miscalibration
1399	Misconnection
2532	Misfire
1401	Misfocusing
1402	Mislabeled
1403	Mislocation
1404	Misplacement
2653	Misshaped Lens (Warped, not round)
1405	Moisture damage
1406	Monitor display alarm, failure of
1407	Monitor failure
1408	Monitor, image quality poor
2160	Motion detector failure
1410	Motor drive unit (MDU) stalled or jammed
1409	Motor failure
NI	NO INFORMATION
NA	NOT APPLICABLE
1414	Needle, dull
1220	Needle, extra
1415	Needle, separation
1416	Needle, unsheathed
2624	No telemetry
2163	Noise
1418	Non-linear
1419	Nonpyrogenic	Free of fever producing substances.
1420	Nonstandard
1421	Nonsterility
1422	Normal
2661	Nozzle Tip Issue, No Description
2663	Nozzle Tip, Rough
2662	Nozzle Tip, Stressed, Split
2423	Obstruction
1423	Occlusion	The act of closing or the state of being closed; an obstruction.
1424	Occlusion, incorrect
1425	Odor
1426	Opaque	Impervious to light; not translucent or only slightly so.
2656	Optic Edge Issue
1863	Osseointegrate, failure to	Failure of direct anchorage of an implant by the formation of bony tissue around the implant without the growth of fibrous tissue at the bone-implant interface.
2408	Osseointegration, loss of
2203	Other (for use when an appropriate device code cannot be identified)
2311	Out-of-box failure
1432	Output above specifications
1431	Output energy incorrect
1433	Output, high
1434	Output, low
1435	Output, none
2342	Overdelivery
2404	Overfill
1437	Overheat
1311	Overinfusion
1438	Oversensing	The pacemaker does not release a stimulus when it is needed because it senses intracorporeal and extracorporeal signals as intrinsic cardial activity.
1439	Pace, failure to
1440	Pacer found in back-up mode
1441	Pacing asynchronously	The occurrence at distinct times of events normally synchronous; disturbance of coordination.
1442	Pacing inadequately
1443	Pacing intermittently
2312	Packaging, incomplete/missing
2385	Packaging, tears, rips, holes in
1444	Packaging, unsealed
1445	Pallet break
1446	Pallet crack(s)
1448	Paramagnetic	The property of being attracted by a magnet, and of assuming a position parallel to that of a magnetic force, but not of becoming permanently magnetized.
1449	Parameter calculations, incorrect	An arbitrary constant in a mathematical expression that distinguishes specific cases; a parameter has a definite fixed value in one case but will have different values in another case.
2508	Paravalvular leak
1450	Paravalvular leak(s)
1451	Particulates	Particles introduced by the device during the procedure.
2424	Patch test, abnormal results of
1454	Peeling
1455	Percutaneous	Effected or performed through the skin.
2205	Perforation
1456	Performance
1458	Phantom problem	In radiology, a device that stimulates the conditions encountered when radiation or radioactive material is deposited in vivo and permits a quantitative estimation of its effects.
1147	Photomultiplier (PM) tube, defective	A photo tube with one or more dynodes between its photocathode and the output electrode.
1459	Pierce
2585	Pipette, failure to aspirate
1460	Pitting
1461	Plugged
1462	Plunge
2669	Plunger Issue, No Description
2671	Plunger Override
2670	Plunger not Aligned Properly
1463	Pocket stimulation	Electrical stimulation of the patient's pocket of skin in which the pulse generator is housed.
1464	Poor gas exchange
1465	Port leak(s)
1466	Portable mode, failure to run on
1467	Positioning difficulties
1469	Potency
1470	Potentiometer readings, high	A potentiometer is a device used for the measurement of an electromotive force by comparison with a known potential difference.
1471	Potentiometer readings, low	A potentiometer is an device used for the measurement of an electromotive force by comparison with a known potential difference.
1474	Power surge
1475	Power, loss of
1473	Power, miscalculation of
1476	Power-up, failure to
1477	Pre/post-pumping problems
1478	Precipitate	A substance separating, in solid particles, from a liquid as the result of a chemical or physical change; to form a precipitate.
1479	Precision
1483	Premature ERI (elective replacement indicator)
1484	Premature deployment
1480	Premature end-of-life (EOL) indicator
1485	Premature explantation
1486	Premature system activation
1487	Prep, difficult to
1488	Prep, failure to
1489	Pressure sensor failure
1490	Pressure, decreased
1491	Pressure, increased
2391	Pressure, insufficient
1492	Prime, failure to
1493	Probe failure
2017	Procedure, improper/incorrect
1494	Product, incorrect
1496	Program, difficult to
1497	Program, failure to
1495	Programming calculations, incorrect
2281	Prompts will not clear
2280	Prompts, inappropriate
2283	Prompts, inaudible voice
2282	Prompts, no voice
1500	Pump speed, decreased
1501	Pump speed, increased
1502	Pump, failure to
1503	Pumping, stopped
1504	Puncture
1505	Pyrogenic	A fever producing substance.
1506	Quality, unsatisfactory or poor
1507	R on T phenomenon	The occurrence of a premature ventricular complex near the peak of the T wave in electrocardiography; it may lead to ventricular tachycardia or fibrillation.
1508	Radiation delivered to incorrect body area
1509	Radiation exposure, unintended
2313	Radiation overexposure
2031	Radiation underexposure
1511	Radio signal problems
2314	Radiofrequency interference (RFI)	Interference from sources of energy outside a system or systems, as contrasted to electromagnetic interference generated inside systems.
1513	Rate modulated pacing sensor, failure of
1514	Reaction
2459	Readings, high
2460	Readings, low
1516	Readings, unable to obtain
1517	Recalibrate, failure to
1518	Recannulation	A tube for insertion into a duct or cavity.
1519	Receiver failure
1520	Receiver stimulator unit, failure of
1521	Record, failure to transmit
1522	Reflux	A backward or return flow.
1523	Regenerate
1524	Rejection
1528	Removal difficulties
1529	Repair
1530	Replace
1531	Reservoir
1532	Reset, failure to
2325	Residue
1533	Resistance, inadequate
1534	Resistance, loss of
2578	Resistance, physical
2043	Respirator, detachment from
1535	Results incorrect
1536	Retract, failure to
1537	Reuse
1538	Reverse osmosis	Membrane separation process for removing solvent from a solution; typically used as a water purification process in hemodialysis.
1539	Rhythm, failure to analyze
1540	Rhythm, failure to convert
1541	Rhythm, failure to diagnose
1542	Rhythm, failure to override
1543	Rhythm, incorrect interpretation of
1544	Rigid
2309	Rinsing, improper
1545	Runaway
1546	Rupture
1547	Rupture due to capsulotomy
1550	Rupture due to damage from surgical instrument
1552	Rupture due to trauma
1548	Rupture, cause unknown
1549	Rupture, fold or crease due to
2167	Safety interlock(s) inadequate
1553	Saline, use of homemade
1554	Salt tablet(s), use of
2533	Samples, failure to obtain
1681	Screw head(s), incorrect
1143	Screw tapper, damaged
2301	Seal, defective
1555	Seal, incorrect
1556	Sediment filter problems	The sediment filters used to remove particulates from the water supply, in order to protect other water treatment equipment or dialysate delivery devices, become clogged or damaged.
1557	Self-activation/keying
2291	Semiautomatic code, failure to override
1558	Sensing intermittently
2293	Sensing, invalid
1559	Sensing, none
1560	Sensitivity
2534	Sensitivity, decreased
2535	Sensitivity, increased
1561	Sensor problems
2547	Separate, failure to
1562	Separates
1563	Service, failure to
1564	Service, inadequate
1565	Shaft break
1566	Shaft, split
2594	Sharp/jagged/rough/etched/scratched
1567	Shelf life exceeded
1568	Shielding failure
1569	Shielding, inadequate
1570	Shipping damage or problem
1571	Shock counters, resetting of
1197	Shock, electrical	The immediate effects produced by the passage of an electric current through any part of the body, e.g., painful stimulation of nerves or tetanic contractions of muscles.
1572	Shock, failure to advise
1573	Shock, failure to deliver
1574	Shock, inappropriate
2287	Shock, intermittent
1575	Short fill
1576	Shoulder rest, detachment of
1577	Shoulder support, detachment of
1578	Shunts, failure of	To provide with or divert by means of an electrical shunt; to divert blood from one part to another by a surgical shunt.
1579	Shutter failure
1580	Side rails, failure of
1582	Signal, failure to select
1583	Size, incorrect
1584	Slippage
1585	Smoke
2324	Solder joint failure
1586	Source, detachment from
1588	Source, incorrect
1587	Source, leak(s) from
1665	Source, unretracted
2595	Spark
2310	Specialty beds, rips/tears in
1589	Specificity
1590	Speech processor failure
2536	Spike, failure to
1591	Spillage, accidental
2537	Splitting
1592	Spring loading mechanism problem
2579	Staples did not form
1594	Steering wire problem
1595	Sterility
1596	Sterilization, inadequate
1597	Sticking
2304	Stopcock valve, failure of	Failure of the stopcock valve to regulate or stop the flow of a fluid through a tubule structure.
1599	Stops intermittently
1600	Storage, inadequate
1601	Stretched
2538	Strikethrough
2506	Structural failure
1602	Strut fracture	Breakage of supporting pieces of a heart valve.
1603	Stuck in inspiratory or expiratory phase
2170	Suction failure
1146	Suction, decreased
1604	Suction, increased
1605	Superheat
1606	Supplier
2323	Surgical graft, failure of
2623	Suspect EMI
1607	Suture line disruption
1608	Suture line separation
1609	Synchronization, inaccurate
1611	Syringe drive problem
1614	Syringe markings inaccurate
2405	Syringe markings, incorrectly placed
1612	Syringe, defective
1613	Syringe, hole(s) in
1619	System fails to activate
1430	System motion, unintended	Any motion of the system or components that was not initiated by the user.
1625	Table break
1626	Table collapse
1623	Table incrementation incorrect
1624	Table top motion, unintended
1622	Table, tilting
1627	Tap water, use of
1628	Tears, rips, holes in device, device material
1629	Telemetry discrepancies	Discrepancies occurring during automatic data measurement and transmission, as by wire or radio, from remote sources, to a receiving station for recording and analysis.
2296	Temperature probe, loose
2457	Test results, high
2456	Test results, inaccurate
2458	Test results, low
1630	Test strips, incompatible
1631	Therapeutic results, unexpected	Use of a medical device for therapeutic purposes.
1632	Threader failure
2574	Threshold, high
1633	Threshold, loss of	Loss of the minimum amount of energy, voltage, or current needed to consistently stimulate the heart muscle.
2575	Threshold, low
1634	Tidal volume fluctuations	The amount of gas that is inspired and expired during one respiratory cycle.
1635	Timer failure
1637	Timer malfunction
1638	Tip breakage
1639	Tomographic pallet crack(s)
1641	Torqued
1642	Tracking
2677	Traditional use
1643	Training, inadequate
1646	Transducer failure
1644	Transducer overheating
1645	Transducer probe overheating
2676	Transitional use
1647	Transmitter failure
1648	Trocar failure	A sharp-pointed instrument equipped with a cannula, used to puncture the wall of a body cavity and withdraw fluid.
1649	Trocar/fiber incompatibility
1650	Trocar/instrument incompatibility
2346	Tube(s), buckling of
2299	Tube(s), defective
1651	Tube(s), exploding of
1652	Tube(s), shattering of
1653	Tube(s), splitting of
1654	Tubing, incorrect placement of
1655	Twisting
UNK	UNKNOWN
1656	Ultrafiltration	The transfer of fluid between the blood and dialysate through the dialysis membrane due to a pressure gradient (transmembrane pressure) existing between the blood and dialysate compartments.
1657	Ultraviolet
1658	Ultraviolet absorbing
2681	Unable to confirm conditions of use
2625	Unable to interrogate
1659	Uncoiled
1660	Undercorrection
2343	Underdelivery
2182	Underinfusion
1661	Undersensing
2636	Unfold, difficult to
1662	Unit inactivated
2204	Unknown (for use when the device problem is not known)
1664	Unravel
1667	Unstable
1668	Unwrap, difficult to
1669	Unwrap, failure to
1671	Vacuum, loss of
2298	Valve(s), defective
1672	Valve(s), failure of
1673	Valve(s), sticking
1674	Vibration
2615	Visibility/palpability
1675	Volume accuracy
1676	Warning light, incorrect
2315	Water purification system, failure of	System used to purify water in hemodialysis.
1677	Water softener process, failure of	Ionic exchange process used in hemodialysis to treat water.
2295	Water softener regeneration cycle, mistiming of	Process which involves the exchange of ions of sodium for the calcium and magnesium in the water supply, thus lowering to an acceptable range the otherwise high levels of these elements typically found in feed water.
1678	Water treatment
1682	Wavelength, incorrect
1679	Wedge filter problem
1680	Wedge, difficult to
2347	Wire(s), breakage of
2614	Wrinkling
2581	Year 2000 (Y2K) related problem
1683	Zero, failure to
2426	pH, high
2425	pH, low

Patient Problem Codes

Problem Code	Problem	Definition
1684	AIDS, acquired immunodeficiency syndrome	A disease characterized by opportunistic infections.
2543	Abdominal cramps
1688	Abortion	The premature expulsion from the uterus of the products of conception, of the embryo or of a nonviable fetus.
2211	Abortion, artificial	Induced abortion.
2212	Abortion, complete	All products of conception are expelled and identified.
2213	Abortion, incomplete	The uterus is not entirely emptied of its contents.
2214	Abortion, induced	Abortion brought on intentionally.
2215	Abortion, missed	Retention in uterus of an abortus that has been dead at least 4 weeks.
2216	Abortion, therapeutic	Abortion induced to save the life or health of a pregnant woman.
1689	Abrasion	Abraded wound; excoriation or circumscribed removal of the superficial layers of the skin or mucous membrane.
1690	Abscess	Circumscribed collection of pus appearing in an acute or chronic, localized infection and associated with tissue destruction and frequent swelling.
1692	Achalasia	Failure of the smooth muscle fibers of the gastrointestinal tract to relax at any one point of junction of one part with another.
1694	Acoustic trauma
1695	Adhesion(s)	The process of adhering or uniting of two surfaces or parts, especially the union of the opposing surfaces of a wound.
1696	Adult respiratory distress syndrome, (ARDS)	Fulminant pulmonary interstitial and alveolar edema, which usually develops a few days after the initiating trauma.
1697	Air embolism	The presence of bubbles of gas in the vascular system; occurrence is related to the entry of air into the venous circulation following trauma or surgery.
1698	Airflow, restricted
1699	Airway obstruction
1701	Allergic reaction	Hypersensitivity; a local or general reaction of an organism following contact with a specific allergen to which it has been previously exposed and to which it has become sensitized.
2673	Altered color perception
2544	Ambulation difficulties
2217	Amnionitis	Inflammation of the amnion.
1702	Amputation
2218	Anaphylactoid	Resembling anaphylaxis.
1704	Anaphylaxis	Systemic anaphylaxis is the most dramatic example of an immediate hypersensitivity reaction; is uncommon and unexpected in nature and occasionally results in a fatal outcome.
1028	Anastomose, failure to	Failure to create an opening by surgical, traumatic, or pathological means between two normally separate spaces or organs.
1705	Anastomosis	An opening created by surgical, traumatic or pathological means between two normally distinct spaces or organs.
1706	Anemia	Equilibrium between blood loss and blood production is disturbed, resulting in a reduction in the number of erythrocytes.
1707	Anesthesia, insufficient, light or patchy	The amount of anesthesia administered to the patient was inadequate.
1708	Aneurysm	A sac formed by the dilation of the wall of an artery, a vein or the heart.
1710	Angina	Severe constricting pain, usually relating to the heart muscle.
1711	Anoxia	Absence or lack of oxygen; reduction of oxygen in body tissues below normal levels.
1713	Antibiotics, reaction to
1714	Anticoagulation	Serving to prevent the coagulation of blood. Any substance that delays, or nullifies coagulation of the blood.
2328	Anxiety
2491	Aortic dissection
1715	Aortic insufficiency	Defective functioning of the aortic valve, with incomplete closure resulting in aortic regurgitation.
1716	Aortic regurgitation	The backward flow of blood from the aorta into the left ventricle, owing to insufficiency of the aortic semilunar valve; it may be chronic or acute.
1717	Aortic stenosis	Narrowing of the orifice of the aortic valve or of the supravalvular or subvalvular regions.
2472	Aortic valve replacement
1718	Apgar score, decreased or low	A numerical expression of a newborn infant's, physical condition, usually determined at 60 seconds after birth.
1719	Apheresis	Any procedure in which blood is withdrawn from a donor, a portion is separated and retained, and the remainder is retransfused into the donor.
2372	Apicectomy	Excision of the apex of the petrous portion of the temporal bone.
1720	Apnea	Cessation of breathing.
2390	Arachnoiditis, spinal	A chronic adhesive arachnoiditis in the spinal arachnoid, with root and spinal cord symptoms similar to those caused by pressure from a tumor.
1721	Arrhythmia	Any variation from the normal sinus rhythm of the heart.
1722	Arteriosclerosis	A group of diseases characterized by thickening and loss of elasticity of arterial walls.
2355	Arthralgia	Pain in a joint.
1723	Arthritis
1724	Arthritis, rheumatoid	A chronic, systemic disease primarily of the joints, usually polyarticular, marked by inflammatory changes in the synovial membranes and articular structures and by muscle atrophy and rarefaction of the bones.
2596	Ascites	Effusion and accumulation of fluid in the abdominal cavity.
1851	Asphyxia	Stopping of the pulse. A condition due to lack of oxygen in respired air, resulting in impending or actual cessation of life.
2209	Asphyxia, fetal	Asphyxia in utero due to hypoxia. See also fetal hypoxia.
1725	Aspiration	The inspiratory sucking into the airways of fluid or a foreign body.
1726	Asthma
1727	Asystole	Cardiac standstill or arrest; absence of a heartbeat.
1728	Atherosclerosis	An extremely common form of arteriosclerosis in which deposits of yellowish plaques containing cholesterol, lipoid material and lipophages are formed within the intima and inner media of large and medium sized arteries.
1729	Atrial fibrillation	An arrhythmia in which minute areas of the atrial myocardium are in various uncoordinated stages of depolarization and repolarization; instead of intermittently contracting, the atria quiver continuously in a chaotic pattern, causing a totally irregular, often rapid ventricular rate.
1730	Atrial flutter	A condition of cardiac arrhythmia in which the atrial contractions are rapid (250 to 350 per minute) but regular.
2511	Atrial perforation
1731	Atrial tachycardia	A rapid cardiac rate usually between 160 and 190 beats per minute.
1732	Autoimmune disease	Any disorder in which destruction of normal tissue arises from humoral or cellular immune responses of the individual to their own tissue constituents; it may be systematic or organ specific.
1733	Autoimmune reaction	The immune response in which antibodies or immune lymphoid cells are produced against the bodies own tissues.
2545	Autotransfusion	Reinfusion of blood or blood products derived from the patient's own circulation.
1736	Biliary cirrhosis	Cirrhosis of the liver due to obstruction or infection of the major extra- or intrahepatic bile ducts.
1738	Bleeding
1739	Bleeding, cerebral	Bleeding within the cerebrum.
1741	Bleeding, intracranial	Bleeding within the cranium.
1742	Blindness	Loss of the sense of sight.
2229	Blinking, excessive
1743	Blister(s)
1744	Bloating
2332	Blockage
1034	Blood gas measurements, abnormal
2451	Blood glucose, high
2450	Blood glucose, low
2597	Blood loss
1747	Blood pooling	Unintended collection/stasis of blood in patient.
2569	Blood pressure, decreased
2488	Blood pressure, high
2548	Blood pressure, increased
2489	Blood pressure, low
2230	Blurring
2461	Body temperature, decreased
2096	Body temperature, elevated
2621	Bone loss
2668	Bowel perforation
1751	Bradycardia	Slowness of the heart beat, as evidenced by slowing of the pulse rate to less than 60.
2394	Brain damage
2219	Brain injury
2546	Breast feed, inability to
2439	Breast lumps
2438	Breast neoplasm	Any new and abnormal growth; specifically a new growth of tissue in which the growth is uncontrolled and progressive.
2401	Breathing difficulties
1752	Bronchitis
2437	Bronchopneumonia	Inflammation of the lungs which usually begins in the terminal bronchioles.
2598	Bronchospasm	Spasmodic contraction of the smooth muscle of the bronchi, as occurs in asthma.
1754	Bruise	An injury of a part without a break in the skin.
1757	Burn(s)	Injury to tissues caused by contact with dry heat, moist heat, flames, chemicals, electricity, friction or radiant and electromagnetic energy. A first degree burn is associated with redness, a second degree burn with vesication and a third degree burn with necrosis through the entire skin.
1756	Burn, bowel
2523	Burn, corneal
2525	Burn, incisional
1755	Burn, radiation	A burn caused by exposure to x-ray, radium, sunlight, atomic or any other type of radiant energy.
2146	Burning sensation
2530	Burns, thermal
1758	Calcification	The process by which organic tissue becomes hardened by a deposit of calcium salts within its substance.
2147	Calcium deposit(s)
1759	Cancer, breast
1760	Cancer, other
2639	Capsular bag tear, posterior
1761	Capsular contracture	The tightening of scar tissue that forms around the implant.
2674	Capsulotomy, anterior
2675	Capsulotomy, posterior
1762	Cardiac arrest	Sudden cessation of the pumping function of the heart, with disappearance of arterial blood pressure, connoting either ventricular fibrillation or ventricular standstill.
2334	Cardiac insufficiency	Insufficiency of the heart muscle or function; see also heart failure.
2226	Cardiac tamponade	Acute compression of the heart caused by increased intrapericardial pressure due to the collection of blood or fluid in the pericardium from rupture of the heart, penetrating trauma, or progressive effusion.
1764	Cardiomyopathy	A general diagnostic term designating primary noninflammatory disease of the heart muscle, often of obscure or unknown etiology.
1765	Cardiopulmonary arrest	Cessation of breathing and/or cardiac function.
1766	Cataract	A loss of the transparency of the lens of the eye or its capsule.
1767	Cataract, induced	A cataract that has been produced artificially or by induction, e.g. as a result of device use, medication, trauma, tears, falls, accidental injury, etc.
2669	Catheterization
2549	Caustic/chemical burns
1768	Cellulitis	An acute, diffuse, spreading, edematous, suppurative inflammation of the deep subcutaneous tissues and sometimes muscle, which may be associated with abscess formation.
2599	Cephalohematoma	A subperiosteal hemorrhage limited to the surface of one cranial bone, a usually benign condition seen in the newborn as a result of bone trauma.
1771	Cerebral, infarction	An ischemic condition of the brain, producing a persistent focal neurological deficit in the area of distribution of the cerebral arteries.
1772	Cerebrospinal fluid leakage
1770	Cerebrovascular accident, (CVA)	See also Stroke Syndrome.
1773	Cervical changes	Changes such as abnormal, pathological, benign, malignant, etc.
1774	Cesarean section (c-section)
2570	Chemical exposure
1775	Chemosis	Excessive edema of the ocular conjunctiva.
1776	Chest pain
2463	Chest tightness/pressure
2191	Chills	Shivering or shaking, accompanied by a sense of cold and pallor of the skin.
2464	Choking
1777	Chorioamnionitis	Inflammation of the chorion and amnion.
2237	Chronic obstructive pulmonary disease, (COPD)	A group of lung disorders characterized by obstruction of air flow, particularly on exhalation. The most common COPD disorders include chronic bronchitis, emphysema, asthma, and bronchiectasis.
2572	Circulation, impaired
2550	Claudication	Limping or lameness.
2626	Closed capsulotomy
2600	Clotting
2228	Clouding, central corneal	Diffuse edema of the central region of the cornea, usually associated with the wearing of hard contact lenses, but may also occur in keratoconus.
1778	Coagulation	Process of clot formation.
1779	Coagulopathy	Any disorder of blood coagulation.
2551	Cognitive changes	Pertaining to or characterized by cognition. That operation of the mind which we become aware of objects of thought or perception; it includes all aspects of perceiving, thinking, or remembering.
2189	Collagen disease	Any of a group of diseases that although clinically distinct and not necessarily related etiologically, have in common widespread pathologic changes in the connective tissue; they include lupus erythematosus, dermatomyositis, scleroderma, polyarteritis nodosa, thrombotic purpura, rheumatic fever, and rheumatoid arthritis.
2416	Collapse
2552	Colostomy	The surgical creation of an opening between the colon and the surface of the body; also used to refer to the opening, or stoma, so created.
2417	Coma	A state of unconsciousness from which the patient cannot be aroused, even by powerful stimulation.
1781	Comatose
2331	Complaint, ill-defined
2627	Complete heart block
2192	Concussion	A violent jar or shock, or the condition which results from such an injury.
2553	Confusion/disorientation
1782	Congenital defect/deformity
1783	Congestive heart failure	A clinical syndrome due to heart disease, characterized by breathlessness and abnormal sodium and water retention, often resulting in edema.
1784	Conjunctivitis	Inflammation of the conjunctiva.
1785	Conjunctivitis, giant papillary	Allergic type of conjunctival inflammation associated with continuous wearing of soft contact lenses. Hard, flat papillae form a cobblestone pattern on undersurface of upper eyelid.
1786	Connective tissue disease	A group of generalized diseases affecting the connective tissue.
2418	Consciousness, loss of
1745	Contamination from blood/fluids	The patient becomes contaminated from contact with blood/fluids on a device.
2455	Contamination, chemical	Patient becomes contaminated from exposure to chemicals associated with the use of the device.
1125	Contraindicated patient	Any special symptom or circumstance that renders the use of a remedy or the carrying out of a procedure inadvisable, usually because of the risk.
1787	Contusion	A bruise; an injury of a part without a break in the skin.
2221	Convulsion	A violent involuntary contraction or series of contractions of the voluntary muscles; seizure.
2222	Convulsion, clonic	A convulsion marked by alternating contracting and relaxing of the muscles.
2223	Convulsion, tonic	Prolonged contraction of the muscles, as the result of an epileptic discharge.
1788	Core temperature rise	Elevation of total body temperature.
1792	Cornea, perforation of
1789	Corneal abrasion	Scraped area of corneal surface, accompanied by a loss of superficial tissue.
1790	Corneal decompensation	Inability to maintain corneal integrity; or corneal edema resulting from failure of the corneal endothelium to maintain detumescence.
1791	Corneal edema	Hazy, swollen cornea.
2173	Corneal implant
2231	Corneal infiltrates	Discrete, small lesions present in the cornea as a result of corneal inflammation and, in some cases, after soft contact lens wear especially extended-wear lenses.
1793	Corneal scar
2233	Corneal sensitivity	The capability of the cornea to respond to stimulation.
1794	Corneal touch	Complications of intraocular lens surgery; usually refers to intraocular lens contact with cornea, can be intermittent or chronic.
1795	Corneal transplant
1796	Corneal ulcer	Area of epithelial tissue loss from corneal surface; associated with inflammatory cells in the cornea and anterior chamber.
2539	Corneal whitening
2193	Cramp(s)	Painful, spasmodic muscular contractions.
1797	Crushing injury	Any type of crushing injury associated with device use or operation.
2656	Cusp Tear
2453	Cut(s)
1798	Cyanosis	A bluish discoloration, applied especially to such discoloration of skin and mucous membranes due to excessive concentration of reduced hemoglobin in the blood.
1799	Cyclitis	Inflammation of the ciliary body.
1800	Cyst(s), formation of
1957	Cytomegaloviral retinitis	Opportunistic infection of the retina by cytomegalovirus, seen in patients with immunodeficiency; symptoms include retinal necrosis and hemorrhage, leading to blindness.
2220	Cytomegalovirus (CVM)	Appearance of enlarged infected cells altering cell formation and possible loss of fetus.
1801	Deafness
1855	Death, intrauterine fetal	Death in utero; failure of the product of conception to show evidence of respiration, heart beat, or definite movement of a voluntary muscle after expulsion from the uterus, with no possibility of resuscitation.
1802	Death/expired
1803	Debris, bone shedding	Shedding of accumulated bone fragments.
2677	Decreased BCVA (Best Corrected Visual Acuity)
2678	Decreased VA, Distant (Visual Acuity)
2679	Decreased VA, Intermediate (Visual Acuity)
2680	Decreased VA, Near (Visual Acuity)
1805	Decreased apgar
1806	Degeneration	Deterioration; change from a higher to a lower form; especially change of tissue to a lower or less functionally active form.
2502	Dehiscence
1807	Dehydrated
1156	Delamination	Division into separate layers.
1808	Dementia	An organic mental syndrome characterized by a general loss of intellectual abilities involving impairment of memory, judgement, and abstract thinking as well as changes in personality.
2224	Dementia, dialysis	A severe, often fatal encephalopathy which has been attributed to accumulation in the brain of aluminum from dialysate prepared with inadequately purified water.
1809	Deposits
2361	Depression
2253	Dermatomyositis	Polymyositis occurring in association with characteristic inflammatory skin changes.
2503	Deterioration
1810	Device induced
2364	Diabetic ketoacidosis	A type of metabolic acidosis produced by accumulation of ketone bodies resulting from uncontrolled diabetes mellitus.
2452	Diaphoretic	Pertaining to or characterized by, or promoting diaphoresis; an agent that produces diaphoresis. (Diaphoresis is the act of perspiration, especially profuse perspiration).
1811	Diarrhea
2670	Difficulty chewing
2676	Diplopia
2371	Disability
2655	Disc impingement
2225	Discharge	An excretion or substance evacuated.
2330	Discomfort
2360	Disfigurement
1813	Disseminated intravascular coagulation (DIC)	A disorder characterized by reduction in the elements involved in blood coagulation due to their utilization in widespread blood clotting within the vessels.
2601	Distention	The state of being distended or enlarged.
2329	Distress
2194	Dizziness	A sensation of unsteadiness with a feeling of movement within the head.
2602	Drainage
1814	Dry eye(s)
2363	Dyskinesia	Difficulty moving; distortion or impairment of voluntary movement, as in tic, spasm, or myoclonus.
1815	Dysphagia	Difficulty in swallowing.
2195	Dysphasia	Impairment of speech.
1816	Dyspnea	Difficult or labored breathing.
1817	EKG/ECG changes	Changes in cardiac electrical activity.
1818	Ecchymosis	A small hemorrhagic spot in the skin or mucous membrane forming a nonelevated, rounded, or irregular blue or purplish spot.
1819	Ectopic pregnancy	Development of the fertilized ovum outside of the uterine cavity.
1820	Edema	Accumulation of an excessive amount of fluid in or around cells, tissues or body cavities.
1822	Edema, macular	Swelling of the macula.
1823	Edema, microcytic	Swelling of abnormally small red blood cells.
1824	Edema, stromal	Fluid from the aqueous humor enters the corneal stroma and causes swelling.
2010	Effusion	The presence of fluid.
2554	Electric shock
1826	Electro-mechanical dissociation	Continued electrical rhythmicity of the heart in the absence of effective mechanical function.
1827	Electrocution	The passage of electrical current through the body.
2196	Electrolyte imbalance	Higher or lower than normal values for the serum electrolytes; usually affecting NA, K, CHL, CO2, glucose, bun.
1829	Embolism	Sudden blocking of an artery by a clot or foreign material which has been brought to its site of lodgement by the blood current.
1830	Embolus	A mass of clotted blood or other formed elements, such as bubbles of air, calcium fragments, etc. brought by the blood from another vessel and forced into a smaller one, thus obstructing the circulation.
1831	Emotional changes
1832	Emphysema, pulmonary	A condition of the lung characterized by increase beyond normal in the size of air spaces distal to the terminal bronchioles, either from dilatation of the alveoli or from destruction of their walls.
2429	Encephalitis	Inflammation of the brain.
1833	Encephalopathy	Any degenerative disease of the brain.
1834	Endocarditis	Inflammation of the endocardium (the endothelial lining membrane of the heart and the connective tissue bed on which it lies).
1835	Endophthalmitis	Inflammation involving the ocular cavities and their adjacent structures.
2236	Endotoxin	Toxic substance from gram-negative bacteria that has a broad spectrum of biological activities, including pyrogenicity.
2327	Entrapment	Patient becomes entangled or caught in side rails of bed.
1838	Enzyme elevation, cardiac
2150	Epithelial marsupialization	Establishing a pouch of what was formerly an enclosed cyst.
1750	Erosion	An eating away or breakdown of any type of external or internal human tissue including but not limited to skin, teeth, mucosa, or somatic, which involves only the outer tissue layer. When tissue surrounds an implanted device, the tissue breakdown may result in migration and loss of the implant material and may result in further complications such as infection or abscess.
1839	Eructate	To belch, the casting of upwind from the stomach.
1840	Erythema	Redness of the skin produced by congestion of the capillaries.
2398	Esophagus, laceration(s) of
2399	Esophagus, perforation of
2628	Exit block
2663	Expulsion
1841	Exsanguination	Extensive loss of blood due to internal or external hemorrhage.
1842	Extravasation	A discharge or escape, as of blood, from a vessel into the tissues.
1843	Extreme exhaustion	Extreme fatigue; inability to respond to stimuli.
1844	Extrusion	Thrusting or pushing out; expulsion by force.
2402	Extubate
1845	Eye injury
1846	Facial nerve paralysis	Weakening or paralysis of the facial nerve.
1847	Fainting	Extremely weak; threatened with syncope.
1848	Fall
2375	Fasciitis	Inflammation of fascia.
1849	Fatigue
1850	Feeding problems
1852	Fetal brain injury	Injury occurring as a result of the delivery process.
1854	Fetal core temperature rise	Elevation of total body temperature.
1856	Fetal distress
1857	Fetal scalp laceration(s)
1858	Fever	Elevation of body temperature above normal.
1859	Fiberoptic fragments, unretrieved in body
1860	Fibromyitis	Inflammation and fibrous degeneration of a muscle.
1861	Fibrosis	The formation of fibrous tissue; fibroid or fibrous degeneration.
2239	First use syndrome	A symptom complex characterized by nervousness, chest pain, back pain, palpations, pruritus, and other usually mild symptoms occurring minutes following the initiation of dialysis with a new dialyzer.
1862	Fistula	An abnormal passage or communication, usually between two internal organs, or leading from an internal organ to the surface of the body.
1864	Flashers	A sudden or brief burst of light.
1865	Flatus	Gas or air in the gastrointestinal tract.
1866	Floaters, vitreous	"Spots before the eyes"; deposits in the vitreous of the eye, usually moving about and probably representing fine aggregates of vitreous protein occurring as a benign degenerative change.
2667	Follow-up bowel resection required
2430	Forced expiratory volume (FEV), decreased	A decrease in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.
2431	Forced expiratory volume (FEV), increased	An increase in the fraction of the forced vital capacity that is exhaled in a specific number of seconds.
1868	Foreign body reaction	A granulomatous inflammatory reaction evoked by the presence of an exogenous material in the tissues, a characteristic feature of which is the formation of foreign body giant cells.
1869	Foreign body sensation	Feeling of grittiness or having something in the eye; frequently caused by a foreign body. Other possible causes include corneal abrasion, corneal ulcer, inturned eye lash or acute conjunctivitis.
2365	Foreign body, removal of
1870	Fracture(s)	The breaking of a part; e.g. a bone, tooth, etc.
2351	Fracture, arm
2369	Fracture, delayed union
2349	Fracture, hip
2077	Fracture, skull
2428	Fracture, tooth
1872	Fungus
1873	Gangrene	Death of tissue, usually in considerable mass and generally associated with loss of vascular (nutritive) supply and followed by bacterial invasion and putrefaction.
1874	Gastritis	Inflammation of the stomach.
1875	Glaucoma	A group of eye diseases characterized by an increase in intraocular pressure which causes pathological changes in the optic disk and typical defects in the field of vision.
1876	Granuloma	Any small nodular delimited aggregation of mononuclear inflammatory cells.
2152	Great vessel perforation	The large vessels entering the heart, including the aorta, the pulmonary arteries and veins, and the venae cavae.
2197	HIV, human immunodeficiency virus	A cytopathic retrovirus. It is the etiological agent of AIDS.
1877	Hair loss
2227	Halo	Hazy ring around bright lights seen by some patients with refractive error or optical defects, e.g. cataracts, or corneal swelling.
1878	Haze
1879	Head injury
1880	Headache
2186	Headache, lumbar puncture	Headache in erect position, after lumbar puncture; due to lowering of intracranial pressure by leakage of cerebrospinal fluid through the needle tract.
2378	Healing, impaired
1881	Hearing impairment
1882	Hearing loss
2206	Heart failure	Inability of the heart to pump blood at an adequate rate to fill tissue metabolic requirements or the ability to do so only at an elevated filling pressure.
2556	Heart rate, decreased
2557	Heart rate, increased
2476	Heart valve repair
1883	Heartburn
2666	Heavier menses
1884	Hematoma	A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel.
2558	Hematuria	Blood in the urine.
1288	Hemoconcentration	An increase in the concentration of blood cells resulting from the loss of plasma or water from the blood stream.
1885	Hemodialysis	The removal of certain elements from the blood by virtue of the difference in the rates of their diffusion through a semipermeable membrane.
1886	Hemolysis	The destruction of red blood cells and the subsequent release of hemoglobin into the plasma.
2279	Hemolytic anemia	An anemia resulting from the destruction of red blood cells.
1887	Hemoptysis	The expectoration of blood or of blood- stained sputum.
1888	Hemorrhage	The escape of blood from the vessels; bleeding.
1889	Hemorrhage, cerebral	Hemorrhage into the cerebrum. See also Stroke Syndrome.
1890	Hemorrhage, extradural	Intracranial hemorrhage into the epidural space.
1891	Hemorrhage, intracranial	Bleeding within the cranium, which may extradural, subdural, subarachnoid, or cerebral.
1892	Hemorrhage, intraventricular	Extravasation of blood into the ventricular system of the brain.
1893	Hemorrhage, subarachnoid	Intracranial hemorrhage into the subarachnoid space.
1894	Hemorrhage, subdural	Cerebral hemorrhage into the subdural space. See also Stroke Syndrome.
2603	Hemorrhage, subgaleal
1895	Hemostasis	The arrest of bleeding, either by the physiological properties of vasoconstriction and coagulation or by surgical means.
1896	Hemothorax	A collection of blood in the pleural cavity.
1897	Hepatitis	Inflammation of the liver.
2240	Hernia	A protrusion of a loop or knuckle or an organ or tissue through an abnormal opening.
1898	Herpes	Any inflammatory skin disease caused by a herpesvirus and characterized by the formation of small vesicles in clusters.
1899	Hiccups
1900	Hives	Urticaria.
2580	Hospitalization required
1297	Host-tissue reaction	Growth of tissue in or around a foreign body as the body's antibody response to the foreign body.
2153	Hot flashes
1901	Hyaloid face, rupture of
1903	Hyperbilirubinemia	Excessive concentrations of bilirubin in the blood, which may lead to jaundice.
1904	Hyperemia	The presence of an increased amount of blood in a part or organ; engorgement.
1905	Hyperglycemia	Abnormally high concentration of glucose in the circulating blood.
2242	Hypernatremia	Excessive amount of sodium in the blood. A hazard associated with the use of softeners in hemodialysis.
1906	Hyperplasia	The abnormal multiplication or increase in the number of normal cells in normal arrangement in a tissue.
1907	Hypersensitivity	A state of altered reactivity in which the body reacts with an exaggerated immune response to a foreign substance.
1908	Hypertension	Persistently high arterial blood pressure.
1909	Hyperthermia	Abnormally high body temperature; especially that induced by therapeutic purposes.
1910	Hyperventilation	Abnormally prolonged, rapid, and deep breathing.
2664	Hypervolemia
1911	Hyphema	Hemorrhage within the anterior chamber of the eye; bloodshot.
2352	Hypoesthesia	Consisting of abnormally decreased sensitivity, particularly to touch.
2353	Hypoesthesia, arm/hand	Consisting of abnormally decreased sensitivity, particularly to touch.
2354	Hypoesthesia, foot/leg	Consisting of abnormally decreased sensitivity, particularly to touch.
1912	Hypoglycemia	An abnormally small concentration of glucose in the blood.
1913	Hypopyon	An accumulation of pus in the anterior chamber of the eye.
1914	Hypotension	Abnormally low blood pressure, as seen in shock.
1915	Hypothermia	Abnormally low body temperature.
1916	Hypoventilation	A state in which there is a reduced amount of air entering the pulmonary alveoli.
2243	Hypovolemia	Abnormally decreased volume of circulating fluid (plasma) in body.
1918	Hypoxia	Decrease below normal levels of oxygen in inspired gases, arterial blood or tissue.
2210	Hypoxia, fetal	Hypoxia in utero, caused by conditions such as inadequate placental function (often abruptio placentae), preeclamptic toxicity, prolapse of the umbilical cord, or complications from anesthetic administration.
*	INVALID DATA
2498	Iatogenic source
1922	Iatrogenic lesion	Denoting any adverse condition in a patient occurring as the result of treatment by a physician or surgeon, especially infections acquired by the patient during the course of the treatment.
2406	Identified diagnosis
1923	Idioventricular rhythm	Relating to or affecting the cardiac ventricles alone.
2672	Immobility of the joint
2156	Immuno-deficiency	A deficiency of immune response or a disorder characterized by deficient immune response.
1924	Implant, failure of	An object or material, such as an alloplastic or radioactive material or tissue, partially or totally inserted or grafted into the body for prosthetic, therapeutic, diagnostic, or experimental purposes.
1925	Impotence	Lack of power.
2155	Improved patient condition
1927	Incompetent cervix	One that is abnormally prone to dilate in the second trimester of pregnancy, resulting in premature expulsion of the fetus.
1928	Incontinence	Inability to control excretory functions.
1930	Infection
1735	Infection, bacterial
2244	Infection, direct	Infection produced by direct contact with another person.
2419	Infection, fungal
2245	Infection, indirect	Infection transmitted by water, food or other means of conveyance.
1933	Infection, intraocular	Infection within the eye.
2246	Infection, pyrogenic	An infection caused by pus-producing organisms.
2247	Infection, subclinical	Infection associated with no detectable symptoms but caused by microorganisms capable of producing easily recognizable diseases, such a poliomyelitis or mumps.
2420	Infection, upper respiratory tract
2120	Infection, urinary tract
2248	Infection, viral
2499	Infective agents
2174	Infiltrates	To penetrate a tissue or substance.
1931	Infiltration	The diffusion or accumulation in a tissue or cells of substances not normal to it or in amounts in excess of the normal.
1932	Inflammation
2348	Injury
1926	Insufficiency, valvular	Dysfunction of one of the cardiac valves, with incomplete valve closure resulting in valvular regurgitation.
2665	Intermenstrual bleeding
1333	Intimal dissection	Pertaining to the inner layer of the blood vessels.
1936	Intraocular pressure (IOP), delayed, uncontrolled	Changes in the fluid pressure inside the eye.
1937	Intraocular pressure rise, (IOPR)	Increase of pressure of the intraocular fluid in the eye.
2662	Intraoperative pain
1938	Intravasation	The entrance of foreign matter into a blood vessel.
2559	Intubation
1940	Iritis	Inflammation of the iris.
2421	Irritability
1941	Irritation
1942	Ischemia	Deficiency of blood in a part due to functional constriction or actual obstruction of a blood vessel.
2493	Ischemic heart disease
1943	Itching
2187	Jaundice	A syndrome characterized by hyperbilirubinemia and deposition of bile pigment in the skin and mucous membranes with a resulting yellow appearance of the patient.
2374	Joint dislocation
2373	Joint disorder
2356	Joint swelling
1944	Keratitis	Inflammation of the cornea.
1945	Keratitis, acanthamoeba	Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear.
1341	LAL test (limulus amebocyte lysate)	An extract of blood cells from the horseshoe crab is exposed to a blood sample from a patient to test for gram negative endotoxin.
2465	Labor, premature
1946	Laceration(s)
2366	Laparotomy	Surgical incision through the flank; abdominal section at any point to gain access to the peritoneal cavity.
1353	Leaflet disruption	A separation of the cusp of a heart valve.
2492	Leaflet disruption due to calcification
2494	Leaflet disruption due to host tissue overgrowth
2495	Leaflet disruption due to infection
2500	Leaflet disruption due to suture abrasion
2496	Leaflet disruption, cause unknown
2201	Leak(s), perivalvular	The escape of blood around a heart valve, particularly around its leaflets.
1947	Left ventricular dysfunction
1948	Left ventricular failure	Failure of adequate output by the left ventricle despite an increase in distending pressure and in end-diastolic volume, with dyspnea, orthopnea, and other signs and symptoms of pulmonary congestion and edema.
1949	Left ventricular hypertrophy	Enlargement or overgrowth of the myocardium of the left ventricle, due to chronic pressure overload.
2641	Lens, replacement of
1950	Lesion	Any pathological or traumatic discontinuity of tissue or loss of function of a part.
1951	Lesions in the target points
2560	Lethargic
1952	Ligament(s), damage to
2671	Limited mobility of the implanted joint
1953	Liver contusion	Bruising of the liver.
1954	Liver dysfunction
1955	Liver laceration(s)
2501	Low cardiac output
2397	Lung, overinflation of
1956	Lupus	A localized destruction or degeneration of the skin caused by various cutaneous diseases.
2359	Malaise	A vague feeling of bodily discomfort and fatigue.
2370	Mammogram, abnormal
2573	Manual ventilation required
2198	Mediastinal shift	Normal location of the mediastinum changes to the right or left, depending upon the underlying cause.
2014	Megophthalmos	Abnormally large eyeball.
1388	Membrane, breakage of
1958	Memory loss
2389	Meningitis	Inflammation of the meninges, usually by either a bacterium or a virus.
1959	Menstrual irregularities	Deviations from the normal process; e.g. delayed, difficult, profuse, scanty, unusual bleeding, etc.
1960	Microcyst(s)	A tiny cyst, frequently of such dimensions that a magnifying lens or microscope is required for observation.
2232	Microcysts, epithelial	Very small, round vesicles containing fluid and cellular debris observed on the surface of the cornea under slit-lamp examination in some types of corneal dystrophy and in wearers of extended-wear lenses.
1961	Microperforation(s)	Small holes made through a part or a substance.
2249	Migration	Pass from one part of the body or organ to another.
1962	Miscarriage	Loss of the products of conception from the uterus before the fetus is viable; spontaneous abortion.
2159	Misdiagnosis	A wrong or mistaken diagnosis.
2561	Missed dose
1963	Mitral insufficiency	Defective functioning of the mitral valve, with incomplete closure resulting in mitral regurgitation.
2512	Mitral perforation
1964	Mitral regurgitation	The backward flow of blood from the left ventricle into the left atrium, owing to insufficiency of the mitral valve; it may be acute or chronic, usually due to mitral valve prolapse, rheumatic heart disease or a complication of cardiac dilatation.
1965	Mitral stenosis	Narrowing of the left atrioventricular mitral orifice.
2471	Mitral valve prolapse	Prolapse of the mitral valve, often with regurgitation, associated with myxomatous proliferation of the leaflets of the mitral valve.
2376	Mitral valve replacement
1966	Muscle spasm(s)	A sudden, violent, involuntary contraction of a muscle or group of muscles.
1412	Muscle stimulation
1967	Muscle weakness
1968	Muscular rigidity	Stiffness or inflexibility.
2161	Muscular tics	An involuntary, compulsive, repetitive stereotyped movement, usually of the face or shoulders.
2238	Myalgia	Pain in a muscle or muscles.
1763	Myocardial contusion	A bruise to the heart.
1969	Myocardial infarction, (MI)	Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in coronary thrombosis.
2470	Myocarditis	Inflammation of the muscular walls of the heart.
NI	NO INFORMATION
NA	NOT APPLICABLE
2466	Nasal obstruction
1970	Nausea	An unpleasant sensation; symptoms resulting from an inclination to vomit.
1971	Necrosis	Pathologic death of one or more cells, or a portion of tissue or organ, resulting from irreversible damage.
1972	Necrosis of flap tissue
1413	Necrosis, pressure	Death of tissue due to external pressure.
2462	Needle stick/puncture
1974	Neonatal deformities
1975	Neonatal hearing impairment
1976	Neonatal hearing loss
1978	Neovascularization	New blood vessel formation in abnormal tissue or in abnormal positions.
1979	Nerve damage
2650	Nerve proximity NOS (not otherwise specified)
1980	Nerve stimulation, undesired
1981	Neural tissue damage
1982	Neurological deficit/dysfunction
1983	Neuropathy	Functional disturbances or pathological changes in the peripheral nervous system.
1417	Nicks, cuts or tears of dura or other tissues by device
2162	Nipple sensation, changes in/loss of
2441	Nipple ulceration
2648	No Patient involvement
2199	No consequences or impact to patient
2250	Nonpyrogenic	Free from fever producing substances.
2276	Nonresorbable materials, unretrieved in body
2411	Nonspecific
2415	Numbness
2422	Obstruction
1984	Occlusion	The act of closure or the state of being closed; an obstruction; the relationship between all of the components of the masticatory system in normal function, dysfunction, and parafunction; momentary complete closure of some area in the vocal tract, causing stoppage of the breath and accumulation of pressure.
1986	Optical nerve damage
1987	Organ(s), perforation of
1428	Ossification	The formation of bone or of a bony substance; the conversion of fibrous tissue or of cartilage into bone or a bony substance.
2649	Osteointegration, inadequate
2377	Osteolysis	Dissolution of bone; applied especially to the removal or loss of the calcium of bone.
2651	Osteopenia
2200	Other (for use when an appropriate patient code cannot be identified)
1436	Overcorrection
1988	Overdose
1989	Overmedicated
1990	Oversedated
1991	Overstimulation
2234	Overwear syndrome	Ocular pain which may be very intense, accompanied by corneal epithelium damage, conjunctival injection, lacrimation, blepharospasm, photophobia and hazy vision following corneal edema caused by overwear of contact lenses, principally the PMMA type.
2478	Oxygen saturation, high	The calculated measurements indicating the degree to which oxygen is bound to hemoglobin is high.
2477	Oxygen saturation, low	The calculated measurements indicating the degree to which oxygen is bound to hemoglobin is low.
1994	Pain
2388	Pain relief, inadequate
1685	Pain, abdominal
2433	Pain, neck
1995	Painful stimulation
2468	Pallor	Paleness; decrease or absence of the skin coloration.
2467	Palpitations	A sensation of an unduly rapid or irregular heart beat.
1447	Pannus formation	Superficial vascularization of the cornea with infiltration of granulation tissue; an inflammatory exudate overlying the lining layer of synovial cells on the inside of a joint.
1997	Paralysis	Loss or impairment of motor function in a part due to lesion of the neural or muscular mechanism.
2448	Paraplegia	Paralysis of the legs and lower part of the body.
1998	Paresis	A slight or incomplete paralysis.
2435	Peak expiratory flowrate, decreased	A decrease of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated.
2436	Peak expiratory flowrate, increased	An increase of the greatest rate of flow that can be achieved during forced expiration beginning with the lungs fully inflated.
1999	Peeling	A peeling off or loss of epidermis, as in sunburn, postscarlatinal peeling, or toxic epidermal necrolysis.
2000	Pelvic inflammatory disease, (PID)	Any pelvic infection involving the upper female genital tract beyond the cervix.
2001	Perforation
2002	Peripheral vascular disease
2003	Peritoneal laceration(s)
2252	Peritonitis	Inflammation of the peritoneum.
2362	Peroneal nerve palsy	Paralysis of the nerves located in the legs.
2367	Pharyngitis	Inflammation of the pharynx.
2004	Phlebitis	Inflammation of a vein.
2164	Phosphene visualization	An objective visual sensation that appears with the eyes closed and in the absence of visual light.
2165	Phototoxicity	A nonimmunologic, chemically induced type of photosensitivity.
2009	Pleomorphism	The assumption of various distinct forms by a single organism or species; also the property of crystallizing in 2 or more forms.
2011	Pneumonia	Inflammation of the lungs with consolidation.
2012	Pneumothorax	Accumulation of air or gas in the pleural space, which may occur spontaneously or as a result of trauma or a pathological process or to be induced deliberately.
2013	Pocket erosion	Erosion of patient's skin pocket which houses a device.
2604	Polydipsia	Chronic excessive intake of water; it may be from an organic cause, such as the dehydration of diabetes mellitus, diabetes insipidus, or a reaction to medication, or from a psychological cause. When untreated it can lead to water intoxication.
1992	Polymyositis	A chronic inflammatory disease of the skeletal muscle, characterized by symmetrical weakness of the limb girdles, neck and pharynx, usually associated with pain and tenderness, and sometimes proceeded or followed by manifestations typical of scleroderma, arthritis, systemic lupus, erythematosus or Sjorgen's Syndrome.
2015	Positive antinuclear antibodies (ANA)	Antibodies directed against nuclear antigens; almost invariably found in systemic lupus erythematosus and are frequently found in rheumatoid arthritis, scleroderma, Sjogren's Syndrome and mixed connective tissue disease.
2642	Postoperative refraction, unexpected
2326	Pressure sores/ulcers
2475	Prolapse	The falling down, or sinking, of a part or viscus.
2514	Protrusion
2605	Pseudoaneurysm	Dilatation and tortuosity of a vessel, giving the appearance of an aneurysm.
2620	Ptosis
2480	Pulmonary arterial wedge pressure, high	The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is high.
2479	Pulmonary arterial wedge pressure, low	The measurement of the mean left pulmonary arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is low.
2481	Pulmonary arterial wedge pressure, normal	The measurement of the mean left arterial pressure, as measured by a catheter introduced into the distal pulmonary artery, is normal.
2019	Pulmonary dysfunction
2020	Pulmonary edema	Abnormal, diffuse, extravascular accumulation of fluid in the pulmonary tissues and air spaces due to changes in hydrostatic forces in the capillaries or to increased capillary permeability.
1498	Pulmonary embolism	The closure of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung.
2021	Pulmonary infarction	Localized necrosis of lung tissue caused by obstruction of the arterial blood supply, most often due to pulmonary embolism.
2022	Pulmonary insufficiency	Defective functioning of the pulmonary valve, with incomplete closure resulting in pulmonic regurgitation.
2023	Pulmonary regurgitation	The backflow of blood from the pulmonary artery into the right ventricle, owing to insufficiency of the pulmonic semilunar valve.
2024	Pulmonary stenosis	Narrowing of the opening between the pulmonary artery and the right ventricle, usually at the level of the valve leaflets.
2474	Pulmonary valve replacement
2606	Pulse, diminished
2469	Pulse, irregular	A pulse that beats at irregular intervals.
2562	Pulse, loss of
2025	Punctured blood vessels
2026	Pupillary block	An obstruction of the pupil.
1812	Purulent discharge	Consisting of or containing pus; associated with the formation of or caused by pus.
2027	Pus	A liquid inflammation product consisting of leukocytes and the debris of dead cells and tissue elements.
2028	Pyrogenic	Inducing fever.
2449	Quadriplegia	Paralysis of all four limbs.
1510	Radiation overdose
2256	Radiation sickness syndrome	Radiation induced skin desquamation
2166	Radiation underdose
2255	Radiodermatitis	A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
2032	Range of motion, loss of
2033	Rash
2034	Raynaud's phenomenon	Intermittent bilateral attacks of ischemia of the fingers or toes and sometimes of the ears or nose, marked by severe pallor, and often accompanied by paresthesia and pain.
2414	Reaction
2442	Reaction, injection site
2035	Reaction, local	A reaction that occurs at or about the site of infection or the point of injection.
2254	Reaction, pyrogenic	A physical response to the presence of endotoxins in the bloodstream, which is characterized by fever and occasionally chills and shaking rigors.
2036	Reaction, systemic	A reaction pertaining to or affecting the body as a whole.
2038	Red eye(s)	Lay term applied to any condition with dilation of conjunctival or ciliary blood vessels; innumerable causes, especially irritation and infection.
2259	Regurgitation	Flow in the opposite direction from normal, as the casting up of undigested food or gas from the stomach, or the backward flowing of blood into the heart, or between the chambers of the heart when a valve is incompetent.
2335	Regurgitation, valvular	Regurgitation of the blood of the heart valves owning to imperfect closing, insufficiency or incompetency of the valves.
2403	Reinfusion
2392	Reintubate
2039	Renal disease (ESRD), end stage	Chronic, irreversible renal failure.
2041	Renal failure	The inability of a kidney to excrete metabolites at normal plasma levels under conditions of normal loading or the inability to retain electrolytes under conditions of normal intake.
1985	Reocclusion
2482	Respiratory acidosis	A state due to excess retention of carbon dioxide in the body.
2483	Respiratory alkalosis	A pathologic condition resulting from accumulation of base, or from loss of acid without comparable loss of base in the body fluids, and characterized by decrease in hydrogen ion concentration.
2044	Respiratory arrest	Cessation of breathing.
2045	Respiratory distress	Difficulty breathing.
2046	Respiratory distress syndrome (RDS) of newborns	A condition of the newborn marked by dyspnea with cyanosis, most frequently occurring in premature infants, children of diabetic mothers and infants delivered by cesarean section, and sometimes with no predisposing cause.
2484	Respiratory failure	A persistent condition of abnormaly low arterial oxygen tension or abnormally high carbon dioxide tension.
2485	Respiratory rate, decreased
2486	Respiratory rate, increased
2400	Resuscitation
2048	Retina, damage to
2049	Retina, degeneration of
2047	Retina, detached
2050	Retina, tear(s) in
2051	Retrograde	Moving backward; degenerating; reversing the normal order of growth and development.
2052	Retrograde flow	Moving backward or against the usual direction of flow.
2053	Rheumatic heart disease	The most important manifestation of and sequel to rheumatic fever, consisting chiefly of valvular deformities.
2054	Right ventricular dysfunction
2055	Right ventricular failure	Failure of proper functioning of the right ventricle, with venous engorgement, hepatic enlargement, and subcutaneous edema.
2056	Right ventricular hypertrophy	Enlargement or overgrowth of the myocardium of the right ventricle, due chronic pressure overload.
2208	Rupture
1551	Rupture due to stress from capsular contracture
2487	ST segment depression	The interval from the end of ventricular depolarization to the onset of the T wave; it is usually isoelectric in normal subjects.
2059	ST segment elevation	Evaluation of the interval from the end of ventricular depolarization to the onset of the T wave; it is usually isoelectric in normal subjects.
2358	Scar excision	Removal of scar tissue.
2060	Scar tissue	Formation of new tissue formed in the healing of a wound.
2061	Scarring
2062	Scleroderma	Chronic hardening and thickening of the skin, which may be a finding in several different diseases, occurring in a localized or focal form and as a systemic disease.
2368	Sedation
2063	Seizures	An attack or recurrence of a disease; a single episode of epilepsy.
2261	Seizures, absence	The seizure seen in absence epilepsy, consisting of a sudden momentary break in consciousness of thought or activity, often accompanied by automatisms or clonic movements, especially of the eyelids.
2260	Seizures, focal	Partial seizure.
2064	Seizures, focal motor	A simple partial seizure consisting of clonus or spasm of a muscle or muscle group; it may be single or in a continuous and repetitive series or may spread to adjacent muscles.
2168	Seizures, grand-mal	A symptomatic form of epilepsy often preceded by an aura; characterized by loss of consciousness with generalized tonic- clonic seizures.
2169	Seizures, petit-mal	Epilepsy characterized by absence seizures.
2065	Sensitivity
2066	Sensitization	Administration of antigen to induce a primary immune response; exposure to allergen that results in the development of hypersensitivity.
2067	Sepsis	The presence in the blood or other tissues of pathogenic microorganisms or their toxins.
2069	Seroma	A tumor-like collection of serum in the tissues.
2070	Severed digit(s), (finger or toe)
2515	Shaking/tremors
2072	Shock	A sudden disturbance of mental equilibrium; a condition of profound hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs.
1693	Shock, acoustic
1703	Shock, anaphylactic	Pertaining to anaphylaxis.
2262	Shock, cardiogenic	Shock resulting from primary failure of the heart in its pumping function, as in myocardial infarction, severe cardiomyopathy, or mechanical obstruction or compression of the heart.
1917	Shock, hypovolemic	Shock resulting from insufficient blood volume for the maintenance of adequate cardiac output, blood pressure and tissue perfusion.
2264	Shock, insulin	A hypoglycemic reaction to overdosage of insulin, a skipped meal, or strenuous exercise in an insulin-dependent diabetic.
2265	Shock, neurogenic	Shock resulting from neurogenic vasodilation, which can be produced by cerebral trauma or hemorrhage, spinal cord injury, deep general or spinal anesthesia, or toxic central nervous system depression.
2266	Shock, postoperative	A state of shock following a surgical operation.
2068	Shock, septic	Shock associated with overwhelming infection, most commonly infection with gram-negative bacteria.
2267	Shock, surgical	Shock that occurs during or after a surgical operation.
2268	Shock, traumatic	Any shock produced by trauma.
2277	Sinus, perforation of
2073	Sjogren's syndrome	A symptom complex of unknown etiology, marked by the triad of keratoconjunctivitis sicca, xerostomia, and the presence of a connective tissue disease, usually rheumatoid arthritis but sometimes systemic lupus erythematosus, scleroderma or polymyositis.
2074	Skin discoloration
2075	Skin erosion	A gradual breakdown or very shallow ulceration of the skin which involves only the epidermis and heals without scarring.
2443	Skin inflammation
2076	Skin irritation
2516	Skin tears
2517	Sleep disturbances
2251	Sneezing
2396	Sore throat
2079	Soreness
2432	Spinal cord injury
2081	Spinal injury
2082	Spotting
2083	Sprain
1593	Stacking breaths	Condition where there are a greater number of inhalations relative to the number of exhalations.
2178	Staining	Associated with contact lens wear, due to an inadequate spreading of the tear film over the cornea as a result of incomplete and/or infrequent blinking.
2058	Staphyloccus aureus	A species comprising the yellow-pigmented, coagulase-positive pathogenic forms of the genus, causing serious suppurative infections and systemic disease; they produce toxins that cause food poisoning and toxic shock syndrome.
2263	Stenosis	Narrowing or stricture of a duct or canal.
2509	Stent distortion
2434	Stiffness, neck
2084	Strangulation	Chocking or arrest of respiration due to occlusion of the air passageway; arrest of circulation in a part due to compression.
2085	Stricture	Decrease in the caliber of a canal, duct, or other passage, as a result of cicatricial contraction or the deposition of abnormal tissue.
2086	Stroke	A sudden and severe attack.
2336	Stroke syndrome	A condition with sudden onset caused by acute vascular lesions of the brain, such as infarction from hemorrhage, embolism, thrombosis or rupturing aneurysm. See also: cerebrovascular accident (CVA), cerebral hemorrhage and subdural hemorrhage.
2087	Subepithelial infiltration
2510	Sudden cardiac death
2088	Suffocation	The stopping of respiration or the asphyxia that results from it.
2089	Sunset syndrome	Decentration, or malposition of intraocular lens; zonular dehiscence or lens malposition caused by zonular or parsplana fixation.
2177	Surgery, prolonged
2640	Surgical incision, enlargement of
2357	Surgical procedure
2563	Surgical procedure aborted/stopped
2564	Surgical procedure, additional
2565	Surgical procedure, delayed
2042	Surgical procedure, repeated
2566	Surgical procedure, unnecessary
2497	Suture abrasion
2444	Sweating
2091	Swelling
2092	Swollen glands
2093	Swollen lymph nodes
1610	Syncope	A temporary suspension of consciousness due to generalized cerebral ischemia; a faint or swoon.
2094	Synovitis	Inflammation of a synovial membrane.
2095	Tachycardia	Rapid beating of the heart, usually applies to a heart rate above 100 beats per minute.
2235	Tearing, excessive
2427	Teeth, sensitivity of
2097	Tentorial tears	Pertaining to tears involving the tentorium of the cerebellum.
2273	Teratogenic effects	An agent or factor that induces or increases the incidence process that affects the production of a malformed fetus.
2099	Therapeutic effects, unexpected
2271	Therapeutic response, decreased
2272	Therapeutic response, increased
2518	Therapy/non-surgical treatment, aborted/stopped
2519	Therapy/non-surgical treatment, additional
2521	Therapy/non-surgical treatment, unncessary
2520	Therapy/non-surgical treatment/delayed/prolonged
2617	Thinning of tissue
2654	Thromboembolism
2100	Thrombosis	Clotting within a blood vessel which may cause infarction of tissues supplied by the vessel.
2101	Thrombus	An aggregation of blood factors, primarily platelets and fibrin with entrapment of cellular elements, frequently causing vascular obstruction at the point of its formation.
2102	Thyroid problems
2171	Tingling	A sensation as of repetitive pin pricks, caused by cold or by striking a nerve, or as a result of various diseases of the central or peripheral nervous system.
2103	Tinnitus	A noise in the ears, such as ringing, buzzing, roaring, clicking.
2681	Tissue Breakdown	A process caused by injury/disease/aging and characterized by a partial/complete disruption of tissue. The disruption may be temporary or permanent and may be associated with either (1) impairment or (2) loss of function of the affected organ(s) or system(s)
2104	Tissue damage
2105	Tissue failure
2106	Tissue, breakdown of optical
2107	Torsades-de-Pointes	"Fringe of pointed tips"; An atypical rapid ventricular tachycardia with periodic waxing and waning of amplitude of the QRS complexes on the electrogram as well as rotation of the complexes about the isoelectric line.
2207	Toxemia	The condition resulting from the spread of bacterial products (toxins) by the bloodstream.
2108	Toxic shock syndrom, (TSS)	A severe illness caused by infection with staphylococcus aureus and characterized by high fever of sudden onset, vomiting, diarrhea, and myalgia, followed by hypotension and in severe cases, shock; a sunburn-like rash with peeling of the skin, especially of the palms and soles, occurs during the acute phase.
2333	Toxicity
2098	Toxins in children	Children affected by toxins may be due to silicone breast implants and their effects on unborn children and from breastfeeding.
2269	Toxoplasmosis, acquired	Acquired as an adult.
2270	Toxoplasmosis, congenital	Passed from mother to fetus.
2393	Tracheostomy	The creation of an opening in the anterior trachea for insertion of a tube to relieve upper airway obstruction and to facilitate ventilation; a surgical creation of an opening into the trachea through the neck.
2337	Transfusion of blood products
1749	Transfusion with incompatible blood
2109	Transient ischemic attack	A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit.
2110	Transplant of organ/tissue
2571	Treatment with medication(s)
2111	Tricuspid insufficiency	Incomplete closure of the tricuspid valve, resulting in tricuspid regurgitation; it is usually secondary to systolic overload in the right ventricle.
2112	Tricuspid regurgitation	The backflow of blood from the right ventricle into the right atrium, owning to imperfect functioning/insufficiency of the tricuspid valve.
2113	Tricuspid stenosis	Narrowing or stricture of the tricuspid orifice of the heart.
2473	Tricuspid valve replacement
2114	Twiddler's syndrome	Dislodgement, breakdown, or other malfunction of an artificial cardiac pacemaker, chemotherapy port, drip infusion valve, or similar implanted diagnostic or therapeutic device as a result of unconscious or habitual manipulation by the patient
2172	Twitching	The occurrence of a single contraction or a series of contractions of a muscle.
2115	UGH (uveitis-glaucoma-hyphema) syndrome	For complications that occur secondary to intraocular lens implantation in the anterior chamber; caused by rubbing of the lens loop (haptics).
UNK	UNKNOWN
2274	Ulcer	A local defect, or excavation of the surface of an organ or tissue, which is produced by the sloughing of inflammatory necrotic tissue.
2116	Ulceration	The formation or development of an ulcer.
2117	Under no medication	Denotes that a patient is resting and not under the influence of any medications.
2118	Under no sedation	Denotes that the patient is resting and not under the influence of any sedatives.
2542	Underdose
2202	Unknown (for use when the patient's condition is not known)
2188	Uremia	An excess in the blood of urea, creatinine, and other nitrogenous end products of protein and amino acid metabolism.
1871	Urgency	A sudden compelling urge to urinate.
2275	Urinary frequency	Urination at short intervals without increase in daily volume of urinary output, due to reduced bladder capacity.
2119	Urinary retention	Accumulation of urine within the bladder because of the inability to urinate.
2278	Urticaria	A vascular reaction, usually transient, involving the upper dermis, representing localized edema caused by dilatation and increased permeability of the capillaries, and marked by the development of wheals.
2121	Uterine perforation
2122	Uveitis	An inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (the sclera, cornea and retina).
2123	Vaginal discharge
2124	Vaginal mucosa damage
2652	Valve Thrombosis
2653	Valve dehiscence
2661	Vaso-vagal response
2126	Vasoconstriction	The diminution of the caliber of vessels, especially constriction of arterioles leading to decreased blood flow to a part.
2127	Vasodilatation	A state of increased caliber of the blood vessels.
2128	Vasospasm	Spasm of the blood vessels, resulting in decrease in their caliber.
2071	Venereal disease (VD)	Any contagious disease acquired during sexual contact; eg. syphilis, gonorrhea, chancroid.
2129	Venipuncture	Puncture of a vein, usually to draw blood or to inject a solution.
2395	Ventilator dependent
2078	Ventricle, abnormality of
2130	Ventricular fibrillation	Arrhythmia characterized by fibrillary contractions of the ventricular muscle due to rapid repetitive excitation of myocardial fibers without coordinated contraction of the ventricle.
2131	Ventricular flutter	A ventricular tachyarrhythmia characterized electrocardiographically by smooth undulating waves with QRS complexes merged with T waves, a rate of approximately 250 per minute.
2513	Ventricular perforation
2132	Ventricular tachycardia	An abnormally rapid ventricular rhythm with aberrant ventricular excitation, usually in excess of 150 beats per minute.
2133	Ventriculomeglia
2134	Vertigo	An illusory sense that either the environment or one's own body is revolving.
1204	Vessel or plaque, device embedded in	Device and/or fragments of device are embedded in patient's vessel and/or plaque.
2135	Vessels, perforation of
2136	Virus
2137	Vision, blurring of
2138	Vision, impaired
2139	Vision, loss of
2140	Visual disturbances
2643	Vitrectomy
2143	Vitreous fluid, blood in
2142	Vitreous fluid, loss of
2445	Vitreous, detachment of
2181	Vitritis	Inflammatory intraocular reaction with clouding and cells in vitreous; often accompanies inflammation of ciliary body, iris, choroid, or retina.
2144	Vomiting
2145	Weakness
2607	Weight fluctuations
2241	Wheal(s)	A smooth, slightly elevated area on the body surface, which is redder or paler than the surrounding skin. It is the typical lesion of urticaria, the dermal evidence of allergy, and in sensitive persons may be provoked by mechanical irritation of the skin.
1154	Wound dehiscence	Separation of the layers of a surgical wound; it may be partial and superficial only, or complete with disruption of all layers.
2446	Wound infection, post-operative
2447	Wound infection, post-traumatic
2613	Wrinkling

Manufacturer Evaluation Method Codes

Evaluation Method Code	Evaluation Method
11	A device from same lot of the actual device involved in incident was evaluated
10	Actual device involved in incident was evaluated
36	Analysis of labeling performed
39	Chemical tests; e.g. corrosion, reaction
21	Computer hardware performance tests conducted
22	Computer software performance tests conducted
20	Device evaluated with respect to operational environment
13	Device from controlled/non-released inventory evaluated
12	Device from reserve sample evaluated
99	ERRONEOUS DATA
25	Electrical tests of all specifications performed
23	Electrical tests performed
82	Environmental tests; temperature, humidity and vibration
89	Filter testing
*	INVALID DATA
30	Mechanical tests of all specifications performed
26	Mechanical tests performed
27	Mechanical tests, dynamic - fatigue test
28	Mechanical tests, static - tension or compression failure
NI	NO INFORMATION
NA	NOT APPLICABLE
84	Optical tests of all specifications performed
86	Other (code unspecified, describe in H.10)
83	Pathological evaluation of returned device (i.e. vascular grafts, heart valves, etc.)
33	Performance tests of all specifications performed
31	Performance tests performed
34	Performed test to determine if incident was the result of interaction with another device(s)
37	Photographic images made during evaluation
U	UNKNOWN
35	User-device interface test performed
38	Visual examination

Manufacturer Evaluation Results Codes

Evaluation Result Code	Evaluation Result
703	Alarms inadequate or absent
101	Component/subassembly failure (select specific code from Category D)
103	Computer hardware problem
104	Computer software problem
105	Computer/human interface problem
705	Controls, switches, keypads difficult to read or use
704	Critical information not displayed
110	Design (unspecified)
115	Design - maintenance difficult
112	Design - not fail safe
114	Design - operational context
111	Design - packaging deficiencies
113	Design - user interface
706	Device difficult to assemble or set up
708	Device performed according to specifications
702	Display hard to read or misleading
120	Electrical problem (unspecified)
122	Electrical problem - open circuit
123	Electrical problem - operating outside specifications
121	Electrical problem - short circuit
197	Electro-magnetic interference problem
198	Electro-static interference
133	End of life - expected
134	End of life - premature
138	Exceeded expected life of device
140	Expected wear/deterioration
141	Failure to cycle
142	Foreign material contamination
196	Inadequate optical transmission
143	Inadequate quality assurance/control
102	Incompatible components
168	Instructions not available
144	Insulation degradation/deterioration
154	Labeling contains inadequate instructions for use/maintenance
157	Labeling contains incorrect instructions for use/maintenance
151	Labeling difficult to read/see
152	Labeling difficult to understand
153	Labeling does not provide necessary information
156	Labeling is incomplete
159	Labeling is not available
150	Labeling problems (unspecified)
145	Lubrication excessive
146	Lubrication insufficient
147	Lubrication, loss of
148	Lubrication, wrong SAE (specifications)
149	Lubrication, wrong type used - oil vs grease
170	Manufacturing
174	Manufacturing - materials
171	Manufacturing - packaging
172	Manufacturing - process
173	Manufacturing - quality control
175	Manufacturing - user interface
135	Material degradation/deterioration, anticipated or expected
137	Material degradation/deterioration, unanticipated or unexpected
136	Material problem - post production
180	Mechanical problem (i.e. pump, motor, wiring, cable, battery, parts, friction, etc.)
710	Negative results of device testing
709	None
707	Operating steps confusing
100	Other (code unspecified, describe in H.10)
190	Out of specification
160	Package insert information inadequate/incorrect
167	Package insert missing
162	Package labeling inadequate/incorrect
163	Package mislabeled
132	Premature RRT indicator (recommended replacement time)
131	Premature power source depletion
191	Quality assurance
164	Service manual (use in conjunction with another labeling code)
192	Shelf life exceeded
195	Sterilization
193	Storage/shipment
194	Telemetry failure
176	Tolerance stack-up (hardware/software)
165	User instruction manual (use in conjunction with another labeling code)
701	User/device interface
201	Cleaning error
213	Device used according to labeled indications
214	Device used in appropriate environment
202	Device used with inappropriate material
215	Device used with incompatible equipment
203	Device used with incompatible medium/material
204	Disinfection error
205	Failure to follow instructions
206	Failure to remove packaging per use instructions
207	Failure to service/maintain according to manufacturer recommendations
208	Incorrect technique/procedure
209	Misapplication/misuse of device
223	Modification of device - by authorized service organization
225	Modification of device - by distributor
224	Modification of device - by other service organization
221	Modification of device - by user/user facility biomedical engineering department
220	Modification of device - unspecified
236	Negative results of device testing
235	None
200	Other (code unspecified, describe in H.10)
230	Reuse of device - unspecified
232	Reuse of device beyond labeled specifications
234	Reuse of device without following disinfection/sterilization instructions
231	Reuse of disposable device
233	Reuse of single use device
211	Timing error
212	Unapproved use of device
311	Anticipated adverse reaction - long term
312	Anticipated adverse reaction - short term
310	Anticipated or known (physiological / procedural related, but code unspecified)
321	Caused by another drug/device
323	Caused by magnetic field - MRI
324	Caused by metal - microwave
325	Caused by operational context
331	Environmental factors
332	High/low temperature or humidity
313	Inherent risk of procedure
314	Known long term complication of procedure
315	Known short term complication of procedure
346	Negative results of device testing
345	None
300	Other (code unspecified, describe in H.10)
333	Patient diagnosis contraindicated use of device
316	Patient's condition - predisposed event
317	Patient's condition affected effectiveness of device
318	Patient's condition contraindicated use of device
322	Related to another drug/device
326	Related to operational context
334	Support system problem (e.g., facility oxygen flow system, electrical Failure of entire facility)
340	Unanticipated (physiological / procedural related, but code unspecified)
341	Unanticipated adverse reaction - long term
342	Unanticipated adverse reaction - short term
343	Unanticipated long term complication of procedure
344	Unanticipated short term complication of procedure
401	Absorber (CO2)
548	Accumulator
402	Actuator
431	Adapter
552	Air cleaner
549	Air pump assembly
403	Alarm
408	Alarm, LED
404	Alarm, assembly
405	Alarm, audible
407	Alarm, high inspiratory pressure
409	Alarm, low inspiratory pressure
410	Alarm, oxygen pressure
411	Alarm, power
412	Alarm, pressure
550	Alarm, self
413	Alarm, visual
414	Alarm, volume
590	Alternator
591	Altimeter
592	Amplifier
593	Analyzer
594	Annunciator
595	Antenna
596	Arrester
597	Attenuator
598	Backpanel
599	Backplane
417	Bacterial filter
730	Baffle
553	Bags
418	Ball
731	Ballast
419	Balloon
732	Barrier
420	Battery
733	Beam splitter
734	Bearings
735	Bell
737	Belt
738	Blower
739	Bobbin
740	Bolometer
741	Bolt
554	Bottom dead center sensor bracket
742	Brake
422	Breathing circuit
743	Brush
745	Bus
746	Bushing
736	Buzzer
428	CO2 monitor
429	CO2 monitor subassembly (only use when part of another device)
437	CPU (central processing unit) board
438	CRT (cathode ray tube)
423	Cable
747	Calibrator
748	Camera
749	Cannula, inner
750	Cannula, outer
424	Cap
751	Capacitor
555	Capacitor (ceramic chip)
752	Carrier
556	Cascade
425	Cassette
753	Caster
754	Cell
426	Charger
755	Chassis
756	Choke
427	Circuit board
757	Clamp
758	Clip
759	Clock
760	Coder
761	Coil
762	Collimator
763	Comparator
557	Compressor (air pump)
558	Concentrator
559	Conductor coil
560	Connecting rod
435	Connector
764	Contact lens
436	Control switches
765	Controller
766	Converter
767	Cooling module
768	Cord
769	Core
770	Counter
771	Coupler
772	Cover
561	Crank arm assembly
773	Crystal
562	Cuff
563	Cup seal
774	Cups
775	Current limiter
776	Current source
439	Cusp
777	Cutter
440	Cylinder
441	Cylinder valve
778	Damper
779	Data acquisition unit
780	Decoder
442	Defibrillator paddles
443	Defibrillator subassembly (only use when part of another device)
781	Dehumidifier
782	Dehydrator
783	Delay line
784	Demagnetizer
785	Demodulator
786	Densitometer
787	Detector
788	Device deployer
789	Dial
445	Diaphragm
790	Digitizer
447	Diode
448	Discrete component/device (resistor, capacitor, diode)
791	Disk
416	Display
792	Divider
793	Dome
794	Doubler
795	Driver
796	Duct
797	Dummy load
798	Duplexer
450	EKG/ECG monitor
449	EKG/ECG subassembly (only use when part of another device)
454	EPROM (erasable programmable read only memory)
452	Electrical lead
451	Electrode
799	Emitter
800	Enclosure
801	Encoder
802	Endoscope
803	Equalizer
804	Evaporator
455	Exhalation filter
805	Expander
806	Extender
807	Extractor
808	Eyelet
813	FET (field effect transistor)
456	Fail-safe system
809	Fan
810	Fastener
811	Feedthru
812	Ferrule
814	Fiber
815	Film
816	Filter
457	Flange
817	Flasher
458	Flowmeter
818	Foil
819	Foot pedal
459	Foot switch
820	Frame
460	Function indicator
564	Function lid
821	Furnace
822	Fuse
461	Gas scavenging
823	Gasket
462	Gauges/meters
824	Gear
565	Gears
825	Generator
826	Grille
827	Grommet
828	Ground strap
829	Guide
463	Guidewire
830	Handset
464	Header
831	Headphone
832	Heads
833	Headset
465	Heart valve cage
466	Heart valve leaflet
834	Heart valve sewing ring
835	Heat exchanger
836	Heat sink
467	Heater
566	Heater rod
567	Helifix coil
837	Hinge
838	Holder
468	Hollow fiber
839	Housing
469	Hub
470	Humidifier
471	Hybrid circuit
474	IC (integrated circuit)
472	IC (integrated circuit) chip
851	IOL (intraocular lens) implant
840	Igniter
841	Imager
842	Impedance converter
843	Indexer
844	Indicator
845	Inductor
473	Insulation
846	Integrator
847	Intercom
569	Interconnection board intubate
848	Interface
849	Interrupter
850	Inverter
852	Isolator
1028	JAW
853	Jack
854	Joint
855	Joystick
856	Jumper
857	Junction
1029	KNIFE
475	Keyboard
858	Keyer
859	Keypad
860	Kit
861	Knob
1030	LATCH
477	LED (light emitting diode)
862	Label
863	Laminate
864	Lamp
865	Laser
476	Lead conductor
866	Lenses
478	Limit switch
867	Limiter
868	Line conditioner
570	Line cord
479	Lithium iodide battery
869	Load
870	Lock
571	Locking sleeve
480	Logic board
572	Lower piston bearing
481	Luer valve
871	Magazine
482	Magnet
872	Magnetizer
873	Magnetometer
874	Magnetoresistor
875	Magnifier
483	Manifold
876	Matrices
484	Membrane
877	Memory
878	Meter
573	Meter needle
879	Microcircuit
880	Microphone
881	Microscope
882	Mirror
883	Mixer
884	Modem
885	Modulator
886	Monitor
485	Mother board
486	Motor
574	Motor roll pin
887	Mount
888	Multiplier
889	Nebulizer (only use when part of another device)
890	Network
1023	None
891	Nuts
487	O2 monitor subassembly (only use when part of another device)
892	O2 sensor
488	Obturator
894	Optical cable
893	Optical disk
546	Optical fiber
895	Optocoupler
896	Oscillator
897	Oscilloscope
400	Other (code unspecified, describe in H.10)
898	Outlet
899	Oven
575	Overlay
489	Oximeter
490	Oximeter (only use when part of another device)
491	Oxygen analyzer
492	PC (printed circuit) board
503	PROM (programmable read only memory)
1031	PUSHER
900	Pad
901	Panel
902	Photodetector
903	Photomultiplier
904	Phototransistor
905	Pickup
493	Pilot balloon valve
906	Pin
578	Piston Pads
576	Piston guides
577	Piston heads
494	Pivot
907	Plate
908	Plotter
579	Plug
910	Pointer
911	Polarizer
495	Port
912	Post
496	Potentiometer
497	Power cord
580	Power lamp
913	Power module
498	Power supply
499	Power switch
914	Preamplifier
915	Prescaler
916	Preselector
500	Pressure sensor
581	Pressure signal
501	Pressure tubing
917	Printer
918	Probe
919	Processor
920	Programmer
504	Prong
921	Protector
922	Proximity switch
923	Pulley
924	Pulser
925	Pump
926	Pyrometer
505	RAM (random access memory)
940	RFI (radio-frequency interference)
509	ROM (read only memory)
927	Rail
928	Reactor
929	Reader
930	Receiver
507	Recorder (tape, stripchart, etc.)
931	Rectifier
582	Reed (electrically open)
932	Regulator
508	Relay
933	Repeater
934	Reservoir
935	Resistor
936	Resolver
937	Resonator
938	Retainer
583	Retaining pin
939	Reticle
941	Rheostat
942	Ribbon
943	Ring
944	Rivet
945	Robot
946	Rod
984	SAW (surface acoustic wave device)
1024	SWITCH, PUSH BUTTON
947	Safety interlock
949	Scale
948	Scaler
950	Scanner
951	Scintillometer
952	Scrambler
953	Screen
568	Screw
954	Scriber
432	Seal
584	Seal tracheal
510	Sensor
551	Servo
955	Shaft
956	Shield
957	Shift register
958	Shifter
959	Shunt
960	Shutter
961	Signal conditioner
962	Simulator
963	Slide
964	Slip ring
965	Slotter line
967	Socket
966	Socket adaptor
511	Solder joint
512	Solenoid
968	Sound absorber
969	Spacer
970	Spark gap
971	Speaker
972	Spectrometer
514	Spirometer
973	Splicer
974	Spooler
975	Spring
976	Stabilizer
977	Stand
515	Stent
516	Stepper motor
978	Stiffener
517	Stopcock
979	Strain relief
980	Strip line
518	Stylet
981	Substrate
982	Sunlamp
983	Suppressor
519	Switches
985	Synchronizer
986	Synthesizer
987	Syringe
1012	TRIAC
988	Table
989	Tachometer
990	Tape
991	Tee
520	Telemetry equipment
992	Telephone
993	Teleprinter
994	Teletypewriter
995	Television unit
996	Temperature compensator
997	Terminal
585	Terminal assembly
998	Terminator
999	Thermistor
1000	Thermocouple
547	Thermocouple wire
1001	Thermometer
1002	Thermostat
1003	Thyristor
1004	Timer
586	Tip conductor coil
1005	Trackball
1006	Transceiver
522	Transducer
523	Transformer
524	Transistor
1007	Translator
1008	Transmission line
1009	Transmitter
1010	Transponder
1011	Transport
1013	Trimmer
525	Tube
587	Tube capillary
1014	Tuner
444	User interface
1025	VALVE CAM
588	VDT (video display terminal)
527	Valve
528	Valve (one-way, hemo, stopcock, etc.)
538	Valve, PEEP (positive end expiratory pressure)
529	Valve, control
530	Valve, directional
589	Valve, dump
531	Valve, exhalation
532	Valve, flap
533	Valve, flow
534	Valve, inhalation
535	Valve, inlet port
536	Valve, inspiratory
537	Valve, outlet port
539	Valve, pressure limit
540	Valve, relief
541	Valve, safety
542	Valve, selector
543	Vaporizer
1015	Varistor
1016	Vibrator
1017	Viewer
1018	Voltmeter
1019	Washer
1020	Waveguide
1021	Window
430	Wire
544	Wiring harness
545	Y-piece connector
1022	Yoke
617	Algorithm analysis
618	Algorithm problem
657	Bus conflicts
633	Bus corruption
652	Cache controller
653	Cache memory
635	Calculation error (pentium)
601	Central processing unit/operating system - error/design
643	Cold
628	Communication
663	Compression errors
603	Computer - user interface
602	Computer hardware problem
605	Computer software problem
616	Computer software problem - error/design
658	Conducted interference
655	DMA controller (direct memory access)
626	Data corruption
631	Deadlock
647	Dirt
646	Dust
664	Electromagnetic interference
648	Electrostatic discharge
89	FILTER TESTING
630	Glitch
642	Heat
645	Humidity
656	I/O (input/output) controller
627	I/O (input/output) integrity
637	Interrupt errors
621	Kernel
638	Latch-up
644	Liquid ingress
606	Magnetic interference
607	Medical diagnosis software
654	Memory access errors
629	Metastable state
608	Modem/communications failure
665	None
600	Other (code unspecified, describe in H.10)
609	Poor image resolution
659	Power fluctuation
610	Power loss/surge related complication
662	Power sequencing
661	Power spike
660	Power transient
640	Power-up errors
611	RF interference
641	Radiation effects
622	Real-time operating system
639	Reset errors
1026	SOFTWARE VALIDATION ERROR
1027	SOFTWARE, FAILURE TO VALIDATE
612	Safety interlock/feature failure
625	Sequence processing
650	Shock
636	Stack errors
619	State machine
651	Temperature fluctuation
634	Timing violation
620	Token
632	Transmission effects
613	User installation error
614	User maintenance error
624	Vector processing
649	Vibration
623	Watchdog
99	ERRONEOUS DATA
NI	NO INFORMATION
NA	NOT APPLICABLE
UNK	UNKNOWN

Manufacturer Conclusion Codes

Conclusion Code	Conclusion
40	Another device caused failure
91	DATE-RELATED PROBLEM, NOT YEAR 2000 (Y2K)
90	DATE-RELATED PROBLEM, YEAR 2000 (Y2K)
97	DEVICE NOT MANUFACTURED BY FIRM
92	DEVICE NOT RETURNED - NO EVALUATION WILL BE PERFORMED
95	DEVICE NOT RETURNED - RESERVE SAMPLES EVALUATED
96	DEVICE NOT RETURNED - SURGERY PENDING
93	DEVICE PROBLEM ALREADY KNOWN - NO EVALUATION WILL BE PERFORMED
94	DEVICE RECEIVED IN A CONDITION THAT MADE ANALYSIS IMPOSSIBLE
70	Device discarded - unable to follow-up
71	Device evaluated and alleged failure could not be duplicated
72	Device evaluated and alleged failure could not be duplicated - cause of event unknown
41	Device failed during assembly
64	Device failed during pre-test/pre-trial
42	Device failed just prior to use
43	Device failure directly caused event
44	Device failure directly contributed to event
45	Device failure indirectly caused event
46	Device failure indirectly contributed to event
47	Device failure occurred and was related to event
48	Device failure occurred but not related to event
49	Device failure related to maintenance
61	Device failure related to user handling
50	Device failure/lack of effectiveness related to patient condition
51	Device maintenance contributed to event
65	Device operated according to specifications
63	Device repaired and returned
52	Device was out of calibration
53	Device was out of specification but this does not relate to event
54	Device was out of specification in a manner that relates to event
99	ERRONEOUS DATA
*	INVALID DATA
55	Intermittent failure directly caused event
56	Intermittent failure directly contributed to event
57	Labeling related
NI	NO INFORMATION
NA	NOT APPLICABLE
67	No conclusion can be drawn
78	No device failure
74	No failure detected and product within specification
75	No failure detected but product out of specification
76	Operational context caused event
77	Operational context contributed to event
68	Other (code unspecified, describe in H.10)
58	Software/firmware caused event
59	Software/firmware contributed to event
88	This is a report of an accidental radiation occurrence (ARO), submitted pursuant to 21 CFR 1002.20
U	UNKNOWN
66	Unusual event
79	User error caused event
80	User error contributed to event
62	User interface contributed to event
60	User-interface caused event

Appendix - B

Device and Patient Problem Codes

Manufacturer Evaluation Method, Manufacturer Evaluation Results, and Manufacturer Conclusion Codes

Device Problem Codes

Patient Problem Codes

Manufacturer Evaluation Method Codes

Manufacturer Evaluation Results Codes

Manufacturer Conclusion Codes