FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1070811
·
Received July 3, 2008
Report
- Report Number
- 3015876-2008-00748
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 6, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM PCB AND THE MEMORY PCB ASSEMBLIES 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 RETURNED ASSEMBLIES, BUT COULD NOT DUPLICATE THE REPORTED FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A HIGH BATTERY CONSUMPTION AND WAS DRAINING THE BATTERIES UNTIL THEY REPORTED FAULTY WHEN ATTEMPTING TO RECHARGE. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
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 |