FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR(R) PLUS DEFIBRILLATOR
MDR report key: 4190107
·
Received October 21, 2014
Report
- Report Number
- 3015876-2014-01250
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- September 26, 2014
- Report Date
- September 26, 2014
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- MKJ
- PMA / PMN Number
- K033275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): PHYSIO-CONTROL ADVISED THE CUSTOMER THAT THEIR DEVICE IS NOT FIELD SERVICEABLE AND NO LONGER UNDER WARRANTY. PHYSIO RECOMMENDED THAT THE CUSTOMER PERMANENTLY REMOVE THE DEVICE FROM SERVICE AND PURCHASE A REPLACEMENT UNIT. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668578 | LIFEPAK CR(R) PLUS DEFIBRILLATOR | DEFIBRILLATORS, AUTOMATIC, EXTERNAL | MKJ | PHYSIO-CONTROL, INC | CRPLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |