FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR SERIES
MDR report key: 1172747
·
Received September 22, 2008
Report
- Report Number
- 3015876-2008-01238
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 4, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL PROVIDED TROUBLESHOOTING ASSISTANCE AND PARTS INFORMATION FOR REPAIR AND REPLACEMENT OF THE THERAPY PCB ASSEMBLY.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE IS DISPLAYING A SERVICE INDICATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 12 DEFIBRILLATOR SERIES | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |