FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 2133244
·
Received May 11, 2011
Report
- Report Number
- 3015876-2011-00372
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 12, 2011
- Report Date
- April 12, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE DEVICE WAS POWERED ON, IT LOST POWER AND WOULD NOT POWER BACK ON. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |