FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1071856
·
Received July 8, 2008
Report
- Report Number
- 3015876-2008-00769
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- January 30, 2008
- Report Date
- January 30, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON AC POWER. THE SERVICE REP 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 ROOT CAUSE FOR THE REPORTED INCIDENT WAS AN ELECTRICAL SHORT THROUGH 2 FET TRANSISTORS, DESIGNATORS Q1 AND Q2.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE AC MAINS LED IS NOT ILLUMINATED WHEN PLUGGED INTO AC POWER AND THE AC LOSS ALERT IS SOUNDING. NO PT WAS ASSOCIATED WITH THE REPORTED INCIDENT.
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 |