FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1070357
·
Received June 30, 2008
Report
- Report Number
- 3015876-2008-00640
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- January 8, 2007
- Report Date
- June 24, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Removal / Correction Number
- Z-0671-2007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE WAS EVALUATED BY PHYSIO-CONTROL. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DUE TO A FAILURE OF THE INTERNAL BATTERY ON THE ANALOG PCB ASSEMBLY. ONE OF THE THREE BATTERY CELL PAIRS, DESIGNATOR BT2, WAS COMPLETELY DEPLETED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED IN RESPONSE TO FIELD ACTION. WHEN THE DEVICE WAS EVALUATED BY THE PHYSIO-CONTROL, IT WAS FOUND THAT ONE OF THE INTERNAL BATTERIES ON THE ANALOG PCB ASSEMBLY WAS DEPLETED. THE DEPLETED BATTERY WOULD RESULT IN A FAILURE OF THE DEVICE TO FUNCTION IF NEEDED FOR DEFIBRILLATION.
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 |