FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1191370
·
Received October 9, 2008
Report
- Report Number
- 1720753-2008-24740
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- July 21, 2008
- Report Date
- August 15, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE WAS 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 9800 SYSTEM HAD NO FLUORO IMAGE AND THE KV AND MA WENT TO MAXIMUM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPOC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |