FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1302928
·
Received December 31, 2008
Report
- Report Number
- 1720753-2008-29492
- Event Type
- Malfunction
- Date Received
- December 31, 2008
- Date of Event
- December 8, 2008
- Report Date
- December 29, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MDR IS RELATED TO GE HEALTHCARE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HIGH VOLTAGE CABLE ON THE 9800 SYSTEM WAS DAMAGED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |