FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1011944
·
Received March 11, 2008
Report
- Report Number
- 3015876-2008-00166
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 13, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT POWER UP ON AC POWER OR IN BATTERY. PHYSIO REPLACED THE THERAPY PCB 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 INCIDENT WAS AN IC CHIP, DESIGNATOR U18.
Description of Event or Problem · 1
FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DEVICE WOULD NOT POWER UP. THERE WAS NO PATIENT 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 |