FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1193137
·
Received October 7, 2008
Report
- Report Number
- 3015876-2008-01458
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 28, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE DIGITAL PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED ASSEMBLY AND OBSERVED THAT THE BOARD WOULD LOCK-UP ON BOOT TEST. THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING ALL THE SERVICE ICONS AND IT WOULD NOT OPERATE ON BATTERY POWER. ALSO, WHEN HOOKED TO A POWER SOURCE, THE DEVICE WOULD POWER ITSELF ON AND LOCK UP. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | CRPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |