FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ALLEGIANCE HEALTHCARE CORP PED RESP CIRC HEATED, 4FT PED RESP CIRC HEATED, 4 FT   back to search results
Model Number 7306-HS3
Event Type  Other   Patient Outcome  Other;
Event Description

Account states circuit melted.

 
Manufacturer Narrative

Customer supplied sample of catalog p/n 7306-hs3 was visually inspected; a melted portion of the tube was detected. After a careful verification of the wire electric terminals it was detected that the crimped metallic terminals of the wire were pulled. Testing done on the internal resistance of the wire identified an unstable reading. It was believed the unstable reading was a result of the damage wire. The damaged wire was cut and recrimped and the resistance reading was repeated and found to be within specification. The assignable root cause could be the result of disconnecting the circuit by pulling it from the wire. This kind of damage to the wire terminal causes an unstable resistance reading.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NamePED RESP CIRC HEATED, 4FT
Type of DevicePED RESP CIRC HEATED, 4 FT
Baseline Brand NamePED RESP CIRC HEATED, 4FT
Baseline Generic NamePEDIATRIC CIRCUIT
Baseline Catalogue Number7306-HS3
Baseline Model Number7306-HS3
Baseline Device FamilyVENTILATION CIRCUIT
Baseline Device 510(K) NumberK915226
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed01/12/1993
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORP
1500 waukegan rd
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP
1500 waukegan rd
mcgaw park IL 60085
Manufacturer Contact
patricia sharpe-gregg
1500 waukegan road
mcgaw park , IL 60085
(847) 578 -3636
Device Event Key302875
MDR Report Key313133
Event Key294345
Report Number1423507-2001-00019
Device Sequence Number1
Product CodeBZE
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/18/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number7306-HS3
Device Catalogue Number7306-HS3
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/22/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Unkown

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH