FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1070673
·
Received July 2, 2008
Report
- Report Number
- 3015876-2008-00731
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 3, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE WOULD FAIL THE USER TEST, ILLUMINATE THE SERVICE LED AND LOG FAULT CODES IN THE ERROR LOG OF DEVICE MEMORY RELATED TO INCORRECT ENERGY LEVELS. PHYSIO REPLACED THE THERAPY 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 IS FAILING USER TEST AND SELF TEST CONSISTENTLY AND THE SERVICE INDICATOR IS ILLUMINATED. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED INCIDENT.
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 |