FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1003242
·
Received February 21, 2008
Report
- Report Number
- 3015876-2008-00082
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- January 25, 2008
- Report Date
- January 25, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT RECOGNIZE NOT OPERATE ON BATTERY POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. FURTHER EVAL OF THE REPLACED POWER SUPPLY ASSEMBLY DETERMINED THAT ROOT CAUSE FOR THE FAILURE TO OPERATE ON BATTERY POWER WAS AN ELECTRICALLY LEAKY FILTER, FL4.
Description of Event or Problem · 1
FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT TURN ON WITH BATTERY POWER. THERE WAS NO PT INVOLVED IN THE REPORTED 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 |