FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1032282
·
Received April 21, 2008
Report
- Report Number
- 3015876-2008-00367
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 24, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN CONTROL KEYPAD ASSEMBLY 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
IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
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 |