FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20E DEFIBRILLATOR/MONITOR
MDR report key: 1112517
·
Received August 11, 2008
Report
- Report Number
- 3015876-2008-00897
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- December 18, 2007
- Report Date
- January 7, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K073089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD CONSTANTLY RE-BOOT WHEN IT WAS POWERED ON. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING ACCEPTANCE TESTING, THE UNIT CONSTANTLY RE-BOOTS ITSELF WHEN SWITCHED ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20E DEFIBRILLATOR/MONITOR | MKJ | PHYSIO-CONTROL, INC. | 20E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |