FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1000588
·
Received February 21, 2008
Report
- Report Number
- 1720753-2008-16324
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 14, 2008
- Report Date
- February 21, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. HOWEVER, IDENTIFIED THAT THE AUTO BRIGHTNESS WAS SET TO OFF AT THE BEGINNING OF CINE RUNS. SET AUTO TO ON AND TESTED SYS. THE SYS WAS FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SVC.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE AUTOMATIC EXPOSURE ON THE 9800 SYS IS NOT WORKING AND THE IMAGE IS POOR. 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 | 36 YR |