FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1003743
·
Received February 22, 2008
Report
- Report Number
- 3015876-2008-00089
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- January 22, 2008
- Report Date
- January 25, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND COULD NOT REPLICATE OR CONFIRM THE REPORTED DEVICE BEHAVIOR. PHYSIO REVIEWED DEVICE OPERATION WITH THE FACILITY AND THEN RETURNED THE DEVICE TO THEM FOR USE.
Description of Event or Problem · 1
FOUND DURING TRAINING/TESTING. ACCORDING TO THE REPORTER, WHEN A BATTERY IS IN BATTERY WELL 2 AND NONE IN BATTERY WELL 1, THE DEVICE OPERATES. IF YOU PUT A BATTERY IN BATTERY WELL 1 WHILE THE DEVICE IS OPERATING ON BATTERY 2, THE DEVICE SHUTS OFF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED 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 |