FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1163634
·
Received September 9, 2008
Report
- Report Number
- 3015876-2008-01083
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 12, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE THERAPY CONNECTOR AND THE THERAPY CABLE 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 REMOVED ASSEMBLIES AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS A LOW VOLTAGE PIN SOCKET, DESIGNATOR #1, THAT WAS DAMAGED AND NOT MAKING CONTACT WITH THE CORRESPONDING PIN ON THE THERAPY CABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING A SERVICE INDICATOR WITH ERROR CODE 1006, INDICATING THAT THE DEFIB CHARGE WAS 15% OUT OF TOLERANCE. THERE WERE NO REPOTS OF 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 |