FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1171936
·
Received September 19, 2008
Report
- Report Number
- 3015876-2008-01225
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 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/MEMORY 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 REMOVED ASSEMBLY, AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS A BROKEN RESISTOR, DESIGNATOR R53, ON THE MEMORY PCB.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED INSTRUMENT OPERATION LOCK-UP. 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 |