FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9900
MDR report key: 1071180
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-23037
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 30, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEM INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER WAS ADJUSTED 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 9900 SYSTEM HAD A POWER OUT OF RANGE ERROR AND ALARM WAS GOING OFF. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEM INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |