FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2191112
·
Received July 25, 2011
Report
- Report Number
- 9680959-2011-01599
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND REPAIRED THE X-RAY TUBE. THE LEFT MONITOR ALSO NEEDED TO BE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY THE DOSAGE AFTER FLUOROSCOPIC X-RAY, AND THE LEFT MONITOR WOULD NOT DISPLAY AN IMAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |