FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1071790
·
Received July 7, 2008
Report
- Report Number
- 3015876-2008-00763
- Event Type
- Malfunction
- Date Received
- July 7, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 12, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED IT INTERMITTENTLY POWER OFF BY ITSELF. PHYSIO REPLACED THE SYSTEM/MEMORY PCBS ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED PCBS ASSEMBLY AND DETERMINED THAT IC CHIP, ON THE SYSTEM PCB WAS ROOT CAUSE FOR THE REPORTED FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE FAILED TO POWER ON USING AC POWER OR BATTERY POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED 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 |