FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2182701
·
Received July 8, 2011
Report
- Report Number
- 9680959-2011-01549
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR COMPUTER WAS REPLACED AND FUNCTIONAL AND DOSE CHECKS WERE PERFORMED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S C-ARM PANEL LIGHTS WERE NOT FUNCTIONING AS INTENDED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |