FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 2954122
·
Received July 12, 2007
Report
- Report Number
- 1720753-2007-08891
- Event Type
- Malfunction
- Date Received
- July 12, 2007
- Date of Event
- June 19, 2007
- Report Date
- July 12, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. ADJUSTED BRIGHTNESS AND CONTRAST SETTINGS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUBTRACTION IMAGE ON THE 9800 SYSTEM WAS TOO LIGHT SUCH THAT THE GUIDE WIRES COULD NOT BE SEEN. NO PT INFO WAS RECORDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |