FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1000867
·
Received February 21, 2008
Report
- Report Number
- 1720753-2008-16271
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO ADD'L INFO AT THIS TIME. WHEN ADD'L INFO IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9800 SYSTEMS AUTOMATIC BRIGHTNESS AND CONTRAST LEVELS ARE NOT WORKING PROPERLY. PHYSICIAN HAD TO MANUALLY ADJUST TO SEE IMAGE. CASES WERE CONTINUED AND THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |