FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1011946
·
Received March 11, 2008
Report
- Report Number
- 3015876-2008-00164
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 12, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE IN BATTERY POWER. PHYSIO REPLACED THE POWER PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
HOSPITAL PERSONNEL RESPONDED TO A PATIENT IN CARDIAC ARREST, THE DEVICE WAS USED TO PROVIDE DEFIBRILLATION THERAPY. ACCORDING TO THE REPORTER, THE DEVICE LOST POWER BY ITSELF AT SOME TIME DURING THE CODE. THERE WERE NO REPORTS OF ANY ADVERSE EFFECTS AS A RESULT OF THE USE OF THE DEVICE.
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 | UNK |