FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1944782
·
Received December 10, 2010
Report
- Report Number
- 3015876-2010-01359
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 6, 2010
- Report Date
- November 12, 2010
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED INTERMITTENT FAILURE. PHYSIO REPLACED THE BATTERY AS A PRECAUTIONARY MEASURE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE POWERED ON AND OFF DURING A PT USE. THE DEVICE USE HAD NO ADVERSE EFFECTS ON THE PT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT PROVIDED.
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 |