FDA Adverse Event
Malfunction
Summary report: N
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 1030236
·
Received April 15, 2008
Report
- Report Number
- 3015876-2008-00335
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 17, 2008
- Report Date
- March 17, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K983393
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED INCIDENT.
Description of Event or Problem · 1
FOUND DURING INSPECTION. ACCORDING TO THE REPORTER, THE DEVICE ILLUMINATED THE SERVICE WRENCH ICON AND DISPLAYED "CALL FOR SERVICE" IN THE DISPLAY. THERE WERE NO REPORTS OF PATIENT USE DURING THE REPORTED EVENT.
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 |