FDA Adverse Event
Malfunction
Summary report: N
HANDLES DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
MDR report key: 1232114
·
Received November 4, 2008
Report
- Report Number
- 3015876-2008-01578
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- August 29, 2008
- Report Date
- September 19, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K935674
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL PROVIDED REPLACEMENT DEVICES TO THE CUSTOMER. PHYSIO WILL EVALUATE THE REPLACED DEVICES UPON RETURN TO REDMOND. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINED THAT THE DISCHARGE SWITCH OF THREE INTERNAL PADDLE ASSEMBLIES WERE JAMMED IN THE "ON" POSITION FOLLOWING A STERILIZATION CYCLE AT 134 DEGREES (CELSIUS) FOR 18 MINUTES. THE CUSTOMER ALSO REPORTED THAT THE INTERNAL PADDLE RUBBER SWITCH BUTTON COVER OF A FOURTH PADDLE ASSEMBLIES HAD SPLIT OPEN AFTER ONE STERILIZATION CYCLE. A JAMMED DISCHARGE SWITCH COULD PREVENT THE DEVICE FROM DELIVERING DEFIBRILLATION THERAPY TO A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HANDLES DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION | LDD | PHYSIO-CONTROL, INC. | NA | MULTI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |