DISCOVERY

Additional Manufacturer Narrative

THE UNIT WAS REMOVED FROM SERVICE AND SERVICE ENGINEER WAS DISPATCHED TO PERFORM EVALUATION AND REPAIR OF THE UNIT. THE FIELD ENGINEER WAS UNABLE TO CONFIRM THE FAILURE OF THE X-RAY TO SHUT OFF. SINCE THE CUSTOMER REPORTED OTHER ERRORS AS WELL, THE FIELD ENGINEER REPLACED SEVERAL COMPONENTS AND VERIFIED PROPER OPERATION OF THE DEVICE. AFTER SEVERAL WEEKS, RADIATION SAFETY OFFICER CONTACTED THE CUSTOMER TO CONFIRM PROPER OPERATION OF THE DEVICE. THE CUSTOMER REPORTED THAT SHE NO LONGER EXPERIENCES THE PROBLEM.

Description of Event or Problem

CUSTOMER CALLED TO REPORT THAT X-RAYS ARE NOT SHUTTING OFF AFTER QC IS DONE AND ALSO AFTER SOME PATIENT SCANS. CUSTOMER REPORTED THAT SHE COULD HEAR THE AUDIBLE HUM PRODUCED BY THE HIGH VOLTAGE TRANSFORMER. SHE RESET THE SYSTEM AND THE PROBLEM WENT AWAY. THE FACT THAT THE X-RAYS WERE ON WAS NOT SUPPORTED BY AN ACTUAL MEASUREMENT. THERE WERE NO INJURY TO ANY PATIENT REPORTED.