FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1941017
·
Received December 8, 2010
Report
- Report Number
- 3015876-2010-01345
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 6, 2010
- Report Date
- November 10, 2010
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFO HAS NOT BEEN SUCCESSFUL. A CONCLUSIVE CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE LOST POWER ON ITS OWN DURING A PT USE. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED. THERE WAS NO ADVERSE EVENT REPORTED AS THE RESULT OF THE DEVICE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |