FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1171941
·
Received September 19, 2008
Report
- Report Number
- 3015876-2008-01224
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 22, 2008
- Report Date
- August 22, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 TRANSISTORS, DESIGNATORS Q1 AND Q2. IT WAS ALSO OBSERVED THAT DIODE D2 WAS ALSO SHORTED AND A FUSE, DESIGNATOR F1, WAS OPEN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD OPERATE ON AC POWER. THERE WAS NOT PATIENT 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 |