FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2994132
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01718
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- January 31, 2013
- Report Date
- February 13, 2013
- 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 REP EVALUATED THE SYSTEM AND PERFORMED A FILAMENT OR GENERATOR CALIBRATION. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR DURING A PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63195 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |