FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1190595
·
Received October 3, 2008
Report
- Report Number
- 3015876-2008-01450
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 3, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE BIPHASIC MODULE 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
IT WAS REPORTED THAT THE DEVICE'S BIPHASIC PCB ASSEMBLY STARTED MAKING CRACKLING AND POPPING SOUNDS AS THE PERFORMANCE INSPECTION PROCEDURE WAS BEING PERFORMED ON THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |