FDA Adverse Event
Malfunction
Summary report: N
OEC 9900 ELITE
MDR report key: 1240688
·
Received November 17, 2008
Report
- Report Number
- 1240688
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- October 29, 2008
- Report Date
- November 17, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
THE C-ARM UNIT'S HARD DRIVE MALFUNCTIONED DURING THE PROCEDURE, RESULTING IN A LOSS OF IMAGES. BASED ON THE MANUFACTURER'S FIELD SERVICE REPORT, THE SYSTEM INITIALLY DISPLAYED INTERMITTENT ERROR MESSAGES REGARDING THE CHARGING SYSTEM AND ITS BATTERIES, WHICH WERE THEN REPLACED. A SECOND SERVICE CALL (SHORTLY AFTERWARDS) INDICATED THAT THE WS IDE DRIVE WAS FOUND CORRUPTED DUE TO IMPROPER SHUTDOWN ISSUES CAUSED BY THE ISD,PCB,AND UPS, ALL OF WHICH WERE DEFECTIVE. ALL WERE REPLACED, AND ADEQUATE OPERATION OF THE SYSTEM WITH THE NEW PARTS, WAS VERIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OEC 9900 ELITE | X-RAY SYSTEM, C-ARM, PORTABLE | JAA | GE OEC MEDICAL SYSTEMS, INC | OEC 9900 ELITE | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |