FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR(R) PLUS DEFIBRILLATOR
MDR report key: 3851687
·
Received June 5, 2014
Report
- Report Number
- 3015876-2014-00622
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 2014
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- MKJ
- PMA / PMN Number
- K033275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN ELECTRICALLY SHORTED CAPACITOR, DESIGNATOR C20 ON THE ANALOG PCB ASSEMBLY. THE SHORTED CAPACITOR OPENED FUSE, DESIGNATOR F1 WHICH PROHIBITED THE DEVICE TO POWER ON. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED ALL THREE ICONS (CHARGE-PAK, ATTENTION, AND SERVICE WRENCH) AND WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329403 | LIFEPAK CR(R) PLUS DEFIBRILLATOR | DEFIBRILLATORS, AUTOMATIC, EXTERNAL | MKJ | PHYSIO-CONTROL, INC | CRPLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |