FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1003749
·
Received February 22, 2008
Report
- Report Number
- 3015876-2008-00088
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- January 24, 2008
- Report Date
- January 24, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN PHYSIO-CONTROL FIRST EVALUATED THE DEVICE, IT WOULD NOT POWER UP. PHYSIO WIPED UP MOST OF THE MOISTURE FROM THE DEVICE AND THEN WARMED IT OVERNIGHT TO DRY. THE DEVICE WAS THEN EVALUATED AND PROPER OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE HAD BEEN LEFT OUTSIDE IN THE RAIN AND IT WOULD NOT POWER UP AFTER BROUGHT INSIDE.
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 |