FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1190623
·
Received October 3, 2008
Report
- Report Number
- 3015876-2008-01454
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 4, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE ANALOG PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS A LEAKY CAPACITOR, DESIGNATOR C177. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A LOW BATTERY CAPACITY AND THE CHARGE PACK AND ATTENTION ICONS WERE ILLUMINATED. THERE WAS NO PT 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 |