FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3033115
·
Received April 1, 2013
Report
- Report Number
- 1720753-2013-04447
- Event Type
- Malfunction
- Date Received
- April 1, 2013
- Date of Event
- January 23, 2013
- Report Date
- April 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE FILAMENT DRIVER BOARD. 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 |
|---|---|---|---|---|---|---|---|
| 132237 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |