FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1003820
·
Received February 26, 2008
Report
- Report Number
- 3015876-2008-00092
- Event Type
- Malfunction
- Date Received
- February 26, 2008
- Date of Event
- January 18, 2008
- Report Date
- February 26, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE, 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 ISSUE WAS AN ELECTRICAL SHORT THROUGH TWO FET TRANSISTORS, DESIGNATORS Q1 AND Q2.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD NO AC OPERATION WHEN THE BATTERY WAS REMOVED, AND NO AC MAINS LIGHT ON. THERE WAS NO PT INVOLVED IN 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 |