FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1082699
·
Received July 23, 2008
Report
- Report Number
- 3015876-2008-00824
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 23, 2008
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- 32045921
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND REPLACED THE SYSTEM CONTROLLER PCB ASSEMBLY. PROPER DEVICE OPERATION WAS THEN OBSERVED AND THE DEVICE WAS RETURNED TO THE CUSTOMER OR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITS A WHITE SCREEN AND IT WILL AUTO RE-BOOT. THERE WAS NO PATIENT USE ASSOCIATED 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 |