FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1062169
·
Received June 13, 2008
Report
- Report Number
- 3015876-2008-00608
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 21, 2008
- Report Date
- May 21, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED FAULT CODES LOGGED INTO DEVICE MEMORY RELATED TO DEVICE POWER-UP AND BOOT-UP ROUTINES. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB 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
ACCORDING TO THE REPORTER, THE DEVICE POWERS UP BY ITSELF, GOES INTO A SELF-TEST ROUTINE AND THEN ILLUMINATES THE SVC LIGHT. THERE WAS NO PT ASSOCIATED WITH THE REPORTED 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 |