FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1191433
·
Received September 26, 2008
Report
- Report Number
- 3015876-2008-01420
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 4, 2008
- Report Date
- August 4, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K973486
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSICO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE INTERFACE PCB ASSEMBLY AND THE KEYPAD ASSEMBLIES. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE RETURNED ASSEMBLIES, AND OBSERVED THAT THE RIGHT SIDE OF THE "ON" BUTTON WAS WORN, ON THE MAIN CONTROL KEYPAD ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD POWER ON AND OFF BY ITSELF. 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 |