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Adverse Event Report

B.BRAUN MEDICAL, INC. CARDIOVASCULAR DIV. GOODTEC FLOW-DIRECTED BALLOON THERMO CATHETER FLOW-DIRECTED BALLOON THERMODILUTION CATHETER   back to search results
Model Number T047(90)
Event Date 09/01/1996
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Complaint stated: open circuit. Analysis determined: thermistor wire became detached from wire leads within thermistor casing causing an unstable reading. Unit was used in vivo. This was not determined until analysis was completed. Remedial action taken: production specs for thermistor placement within the port has been revised to alleviate this type of failure. Both the frequency and severity of this type of incident will be closely monitored to determine if further remedial action is necessary.

 
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Brand NameGOODTEC FLOW-DIRECTED BALLOON THERMO CATHETER
Type of DeviceFLOW-DIRECTED BALLOON THERMODILUTION CATHETER
Baseline Brand NameGOODTEC THERMODILUTION BALLOON CATHETER
Baseline Generic NameFLOW-DIRECTED BALLOON THERMODILUTION CATHETER
Baseline Catalogue Number417D1022/I
Baseline Model NumberT047(90)
Other Baseline ID NumberPN604028
Baseline Device FamilyTHERMODILUTION CATHETER (PVC)
Baseline Device 510(K) NumberK812761
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed11/02/1981
Manufacturer (Section F)
B.BRAUN MEDICAL, INC. CARDIOVASCULAR DIV.
18 olney ave
cherry hill NJ 08003 1607
Manufacturer (Section D)
B.BRAUN MEDICAL, INC. CARDIOVASCULAR DIV.
18 olney ave
cherry hill NJ 08003 1607
Manufacturer (Section G)
B. BRAUN MEDICAL, INC.
1940 olney ave, ste 200
cherry hill NJ 08003 1607
Manufacturer Contact
chris watt
18 olney ave, bldg. #44
cherry hill , NJ 08003-1607
(609) 751 -2080 ext 114
Device Event Key59983
MDR Report Key59562
Event Key55985
Report Number2243801-1996-00021
Device Sequence Number1
Product CodeDYG
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/04/1996
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/24/1996
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device EXPIRATION Date04/30/1998
Device MODEL NumberT047(90)
Device Catalogue Number417D1022/I
Device LOT NumberM495360
OTHER Device ID NumberPN 604028
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/1996
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Invalid Data
Date Manufacturer Received11/05/1996
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1996
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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