FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 15 MONITOR/DEFIBRILLATOR
MDR report key: 2073114
·
Received March 17, 2011
Report
- Report Number
- 3015876-2011-00246
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K082937
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PATIENT CARE, THE DEVICE WOULD NOT POWER ON. THE END USER ATTEMPTED AGAIN WITH A DIFFERENT SET OF BATTERIES WITH THE SAME RESULT. THERE WAS AN APPROXIMATE DELAY IN CARE OF 4-5 MINUTES WHEN THE PATIENT WAS ADMITTED TO THE LOCAL HOSPITAL. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT FROM RESULT OF THE REPORTED FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | 15 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |