FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2181012
·
Received July 7, 2011
Report
- Report Number
- 1720753-2011-08806
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 23, 2011
- Report Date
- July 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE X-RAY TUBE, THE TUBE SENSOR, THE TUBE COVER, AND THE FILAMENT DRIVER PRINTED CIRCUIT BOARD, AS WELL AS THE INTERCONNECT CABLE, AND THE LEMO RECEPTACLE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM MONITOR WOULD GO FROM BLACK TO WHITE, AND DISPLAY A FILAMENT FAILURE ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |