FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2093441
·
Received May 4, 2011
Report
- Report Number
- 1720753-2011-06936
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 15, 2011
- Report Date
- May 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. DURING THE SERVICE CALL, THE FLUORO FUNCTION BOARD WAS ADJUSTED AND FLASHED, THE GENERATOR INTERFACE BOARD NODES WERE FLASHED, THE CALIBRATION FILES WERE RELOADED, AND THE INTERCONNECT CABLE WAS REPLACED. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS AVAILABLE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM CONTINUED TO PERFORM FLUOROSCOPY AND THE EMERGENCY STOP NEEDED TO BE PUSHED TO HALT EXPOSURE. 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 |