FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1012861
·
Received March 12, 2008
Report
- Report Number
- 3015876-2008-00173
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 4, 2008
- Report Date
- February 15, 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
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTRL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON AC 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 ASSEMBLY AND DETERMINED THAT ROOT CAUSE FOR THE REPORTED EVENT WAS ELECTRICALLY SHORTED FET TRANSISTORS, DESIGNATORS Q1 AND Q2.
Description of Event or Problem · 1
FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT OPERATE ON AC POWER. THERE WAS NO PT INVOLVEMENT REPORTED 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 |