FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1033496
·
Received April 23, 2008
Report
- Report Number
- 3015876-2008-00377
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 21, 2008
- Report Date
- March 25, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT OPERATION WOULD INTERMITTENTLY LOCK UP. PHYSIO REPLACED THE USER INTERFACE TO STACK CONNECTOR FLEX CABLE, DESIGNATOR W18, 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
ACCORDING TO THE REPORTER, THE DEVICE INTERMITTENTLY LOCKS UP UPON POWER-ON WITH FROZEN WHITE DISPLAY. 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 |