FDA Adverse Event
Malfunction
Summary report: N
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1082783
·
Received July 24, 2008
Report
- Report Number
- 3015876-2008-00828
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 25, 2008
- Report Date
- June 25, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DECLINED AN OFFER OF SERVICE FROM PHYSIO-CONTROL, AND INDICATED THE FACILITY WILL REPLACE THE DEVICE WITH ANOTHER AED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE IS DISPLAYING THE SERVICE WRENCH ICON AND HAS A FAULT CODE IN DEVICE MEMORY THAT RELATES TO THE BIPHASIC ENERGY CIRCUITRY AND INDICATES A POSSIBLE FAILURE OF THE DEVICE TO DELIVER THE EXPECTED LEVEL OF ENERGY.
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 |