FDA Adverse Event
Malfunction
Summary report: N
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBIRLLATOR
MDR report key: 1190620
·
Received October 3, 2008
Report
- Report Number
- 3015876-2008-01451
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- August 20, 2008
- Report Date
- September 4, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN PCB ASSEMBLY AND THEN 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 THE DEVICE WOULD NOT POWER ON. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBIRLLATOR | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |