FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1172749
·
Received September 22, 2008
Report
- Report Number
- 3015876-2008-01241
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 12, 2008
- Report Date
- August 12, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON BATTERY POWER. 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 FURTHER EVALUATED THE REPLACED POWER SUPPLY ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE FOR THE REPORTED INCIDENT WAS AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL4, DUE TO SOLDER FLUX RESIDUE ON THE PCB.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WILL NOT OPERATE ON BATTERY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORT.
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 |