FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1030237
·
Received April 15, 2008
Report
- Report Number
- 3015876-2008-00337
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 14, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL OPENED THE DEVICE AND OBSERVED THAT A CONNECTOR JACK, DESIGNATOR J23, ON THE THERAPY PCB ASSEMBLY WAS BROKEN. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
WHILE PERFORMING A PERIODIC INSPECTION AND TESTING OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE DEFIBRILLATOR WOULD NOT CHARGE. THERE WAS NO PATIENT INVOLVED 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 |