FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIRBILLATOR
MDR report key: 1120586
·
Received August 12, 2008
Report
- Report Number
- 3015876-2008-00936
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- June 25, 2008
- Report Date
- July 14, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE, BUT COULD NOT DUPLICATE THE REPORTED FAILURE. IT WAS OBSERVED THAT A CAPACITOR, DESIGNATOR, WAS LOOSE INSIDE OF THE DEVICE. THE CUSTOMER RECEIVED A REPLACEMENT UNIT. THE ROOT CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO BE THE LOOSE CAPACITOR, DESIGNATOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING A SERVICE WRENCH INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIRBILLATOR | MKJ | PHYSIO-CONTROL, INC. | CRPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |