FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1021910
·
Received March 28, 2008
Report
- Report Number
- 3015876-2008-00237
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- January 28, 2008
- Report Date
- February 27, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE BATTERY 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 BATTERY ASSEMBLY AND OBSERVED THAT ONE CELL DROPS TO <1.5 VOLTS AND DECREASES WHILE UNDER LOAD. ALSO, THE PCB HAS CONTAMINATION IN SERVERAL LOCATIONS ON THE BOARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WILL KEEP REBOOTING AND NEVER GIVE THE "CONNECT ELECTRODES" PROMPT. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |