FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 905977
·
Received August 30, 2007
Report
- Report Number
- 1720753-2007-04918
- Event Type
- Malfunction
- Date Received
- August 30, 2007
- Date of Event
- June 27, 2007
- Report Date
- August 30, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE HARD DRIVE AND GENERATOR INTERFACE BOARD (GIE). RELOADED FLASH. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEM HAS MIXED UP IMAGES, THE SCREEN LOCKS UP (RETRIEVING CINE RUNS) AND FLASHES "LIVE" WITH NO FLUORO. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |