FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2021653
·
Received February 21, 2011
Report
- Report Number
- 1720753-2011-01518
- Event Type
- Malfunction
- Date Received
- February 21, 2011
- Date of Event
- December 10, 2010
- Report Date
- February 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS CLEANED AND RE-GREASED DURING THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM WOULD NOT FLUORO AT BOOT UP. ALSO, THE SCREEN WAS BLANK AND THE X-RAY TUBE MADE NOISE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |