FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 2030362
·
Received March 21, 2011
Report
- Report Number
- 3015876-2011-00259
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 20, 2011
- Report Date
- February 20, 2011
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE LOANER POOL FOR USE.
Description of Event or Problem · 1
DURING AN INSPECTION OF A LOANER DEVICE OWNED BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER ON WITH AC OR DC POWER. THERE WAS NO PT USE ASSOCIATED WITH THE OBSERVED FAILURE.
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 |