FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1013288
·
Received March 14, 2008
Report
- Report Number
- 3015876-2008-00184
- Event Type
- Malfunction
- Date Received
- March 14, 2008
- Date of Event
- February 20, 2008
- Report Date
- February 20, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K955854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER DECLINED AN OFFER OF SVC FROM PHYSIO-CONTROL. THE CUSTOMER IS REPLACING IT WITH NEWER DEVICE BECAUSE IT IS ALMOST 9 YEARS OLD AND OUT OF WARRANTY.
Description of Event or Problem · 1
FOUND DURING INSPECTION. ACCORDING TO THE REPORTER, THE DEVICE IS DISPLAYING A FLASHING SVC WRENCH ICON. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED INCIDENT.
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 |