FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2160364
·
Received June 20, 2011
Report
- Report Number
- 1720753-2011-08222
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP DETERMINED THAT THERE WAS NO VIDEO FROM THE CLOSED CIRCUIT DIGITAL CAMERA. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD ONLY DISPLAY A WHITE IMAGE. NO PT 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 |