FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 2221783
·
Received August 17, 2011
Report
- Report Number
- 3015876-2011-00606
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 20, 2011
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO REPLACED THE THERAPY CONNECTOR ASSEMBLY BECAUSE OF TWO BROKEN MALE PINS STUCK INSIDE THE CONNECTOR, AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD TWO BROKEN PINS STUCK INSIDE THE THERAPY CONNECTOR ASSEMBLY, PROHIBITING THE DEVICE FROM HAVING THE ABILITY TO DELIVERY DEFIBRILLATION THERAPY. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |