FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2093395
·
Received May 4, 2011
Report
- Report Number
- 1720753-2011-06923
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 11, 2011
- Report Date
- May 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. A FILAMENT CALIBRATION WAS PERFORMED AND THE SYSTEM BATTERIES WERE CHECKED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC. 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 A FILAMENT REGULATOR ERROR MESSAGE. 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 |