FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1082012
·
Received July 22, 2008
Report
- Report Number
- 3015876-2008-00814
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 23, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE FOR THE REPORTED FAILURE WAS AN ELECTRICAL SHORT THROUGH FET TRANSISTOR DESIGNATOR Q6. IT WAS ALSO OBSERVED THAT A FUSE, DESIGNATOR F1, WAS OPENED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON AC POWER. THERE WAS NO PT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |