FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1973729
·
Received January 17, 2011
Report
- Report Number
- 1720753-2011-00326
- Event Type
- Malfunction
- Date Received
- January 17, 2011
- Date of Event
- December 21, 2010
- Report Date
- January 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. IN ORDER TO ALIGN BEAM THE C-ARM CAMERA NEEDED TO BE ADJUSTED, HOWEVER THE CAMERA WAS AN AFTER MARKET TYPE, NOT AN OEC. THE SERVICE CALL WAS CANCELLED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM WAS WRITTEN UP BY THE STATE PHYSICIST FOR BEAM ALIGNMENT OUT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |