FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1120088
·
Received August 15, 2008
Report
- Report Number
- 3015876-2008-00954
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 18, 2008
- Report Date
- July 18, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL REPLACED THE BATTERY PACK 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
PHYSIO-CONTROL WAS PERFORMING A CONTRACT INSPECTION, TESTING, AND MAINTENANCE OF THE FACILITY'S DEVICES. DURING TESTING OF THE DEVICE, PHYSIO OBSERVED THAT IT WOULD POWER OFF AND THEN ON AGAIN BY ITSELF. THERE WAS NO PT INVOLVED WITH THE REPORTED INCIDENT.
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 |