FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 2080039
·
Received April 6, 2011
Report
- Report Number
- 3015876-2011-00306
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPORTED POWER PCB ASSEMBLY AND DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE A SHORTED INTEGRATED CIRCUIT CHIP, DESIGNATOR U5.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON WITH AC OR DC POWER. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.
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 |