FDA Adverse Event
Malfunction
Summary report: N
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1171975
·
Received September 18, 2008
Report
- Report Number
- 3015876-2008-01201
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THE DEVICE LOCK UP WHEN THE ON BUTTON WAS PRESSED. 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
THE CUSTOMER REPORTED THAT THE DEVICE IS DISPLAYING THE BATTERY AND SERVICE WRENCH ICONS AND WON'T POWER UP PROPERLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |