FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2183540
·
Received July 11, 2011
Report
- Report Number
- 1720753-2011-08891
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR PRINTED CIRCUIT BOARDS WERE RESEATED AND THE VOLTAGES WERE VERIFIED. THE FILAMENT WAS CALIBRATED AND THE NEW VALUES BACKED UP. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED FILAMENT REGULATOR ERROR MESSAGES ON THE C-RAM DISPLAY WHICH WERE RESOLVED BY DEPRESSING ANY BUTTON. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |