FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9600
MDR report key: 1071185
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-23032
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 2, 2008
- Report Date
- June 30, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEM INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE KEY SWITCH AND THE X-RAY REGULATOR BOARD WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEY FOR THE 9600 SYSTEM WAS BROKEN OFF IN THE SWITCH. ALSO THE SYSTEM WOULD INTERMITTENTLY NOT FLUORO. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEM INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |