FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2960635
·
Received January 25, 2013
Report
- Report Number
- 9680959-2013-00231
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 25, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A BLOWN FUSE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE FSE REPORTED THAT THE CART MONITORS COULD NOT DISPLAY IMAGES. THIS ISSUE WOULD PREVENT THE LIVE IMAGE FROM BEING VIEWED, THEREBY MAKING THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35377 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |