FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2960795
·
Received January 30, 2013
Report
- Report Number
- 9680959-2013-00273
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 30, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE TOUCHSCREEN. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE FSE REPORTED THAT THE SYSTEM WOULD NOT START UP. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41221 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |