FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1153655
·
Received September 11, 2008
Report
- Report Number
- 1720753-2008-22289
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- May 28, 2008
- Report Date
- June 6, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ON SITE INVESTIGATION OF THE SYSTEM. THE REP CHECKED AC AND DC VOLTAGES, RESEATED BOARDS AND CABLES, REGREASED HV CABLES, REPLACED X-RAY CONTROL BATTERY, ERASED AND RELOADED FLASH MEMORY AND CALIBRATIONS, AND RAN FILAMENT CALIBRATION. THE SYSTEM NOW FUNCTIONS AS INTENDED, AND WAS RETURNED FOR CUSTOMER USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A POPPING NOISE HEARD FROM THE X-RAY TUBE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |