FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1191391
·
Received September 26, 2008
Report
- Report Number
- 3015876-2008-01390
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 28, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K973486
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE INTERFACE PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS A SHORTED AND BURNED CAPACITOR, DESIGNATOR C14.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE FAILED TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |