FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2202256
·
Received August 5, 2011
Report
- Report Number
- 9680959-2011-01675
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE KV WERE ADJUSTED TO 108 KV HIGH AND THE MILLIAMPERES REMAINED AT 0. THE SYSTEM REMAINS IN NEED OF ADD'L REPAIR WHICH IS PLANNED AND THE CUSTOMER IS INFORMED OF THE SYSTEM'S STATUS. NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PRODUCE FLUOROSCOPIC X-RAYS AND THE TEMPERATURE SYMBOL WAS FLASHING. 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 |