FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 4131870
·
Received October 1, 2014
Report
- Report Number
- 3015876-2014-01155
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- MKJ
- PMA / PMN Number
- K102972
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE OR VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER SEVERAL NIBP MEASUREMENTS COMPLETED BY THEIR DEVICE, THE DEVICE LOST POWER. THERE WAS NO ADDITIONAL INFORMATION ON THE PATIENT OR THE EVENT PROVIDED. NO ADVERSE EFFECTS WERE REPORTED TO HAVE TAKEN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611361 | LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES | DEFIBRILLATORS, AUTOMATIC, EXTERNAL | MKJ | PHYSIO-CONTROL, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |