FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2934843
·
Received January 4, 2013
Report
- Report Number
- 1720753-2013-00156
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 19, 2012
- Report Date
- January 4, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A BLACK SCREEN WITH WHITE STARS WHEN THE C-ARM WAS MOVED FROM AN AP POSITION TO A LATERAL POSITION. THIS CAUSED A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5637 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |