FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1031685
·
Received April 18, 2008
Report
- Report Number
- 3015876-2008-00358
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- March 19, 2008
- Report Date
- March 20, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT POWER UP WITH 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. FURTHER EVAL OF THE REPLACED POWER SUPPLY ASSEMBLY DETERMINED THAT ROOT CAUSE FOR THE REPORTED EVENT WAS AN ELECTRICAL SHORT THROUGH 2 TRANSISTORS, DESIGNATED Q1 AND Q2.
Description of Event or Problem · 1
FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT POWER UP IN AC. 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 |