FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 15 MONITOR/DEFIBRILLATOR
MDR report key: 1941016
·
Received December 8, 2010
Report
- Report Number
- 3015876-2010-01344
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 8, 2010
- Report Date
- November 8, 2010
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K082937
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE TO POWER ON. PHYSIO REPLACED THE MAIN CONTROL KEYPAD 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
IT WAS REPORTED THAT THE DEVICE WOULD INTERMITTENTLY FAIL TO POWER ON WITH KNOWN GOOD BATTERIES. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | 15 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |