FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1013997
·
Received March 13, 2008
Report
- Report Number
- 3015876-2008-00177
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- February 14, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON BATTERY. 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.
Description of Event or Problem · 1
FOUND DURING TESTING. ACCORDING TO THE REPORTER, THE DEVICE WILL NOT OPERATE ON BATTERY POWER. 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 |