FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2181495
·
Received July 7, 2011
Report
- Report Number
- 9680959-2011-01542
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 24, 2011
- Report Date
- July 7, 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. THE TWO AMPERE PINS WERE RESOLDERED, THE IMAGE MECHANISMS WERE REPAIRED AND THE SOFTWARE WAS UPGRADED. 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'S MONITORS DISPLAYED DEGRADED IMAGE QUALITY AND WOULD NOT POWER ON. 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 |