FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2960782
·
Received January 30, 2013
Report
- Report Number
- 9680959-2013-00274
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 18, 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 REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS NOT AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR WAS NOT WORKING. THIS WOULD RESULT IN NO LIVE IMAGE BEING DISPLAYED. THERE IS NO REPORT OF INJURY OF DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39968 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |