FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2021952
·
Received February 25, 2011
Report
- Report Number
- 9680959-2011-00590
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SVC REP PERFORMED AN ON SITE INVESTIGATION. THE SVC REP WAS UNABLE TO FIX THE KEY SWITCH REMOTELY. NO FURTHER INFO IS AVAILABLE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY CAN SCREEN ON THE 7900 SYSTEM WITHOUT THE KEY BEING TURNED ON. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |