DISCOVERY
Received Mar 10, 2009 · Event occurred Feb 11, 2009
Report 1221300-2009-00001 · MDR key 1377750
Device
Product problems
- Mechanical Problem
- Device Remains Activated
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER CALLED TO REPORT THAT THE UNIT IS MAKING CLICKING NOISE AND THAT THE X-RAY LIGHT STAYS ON AFTER THE SCAN HAS ENDED. THERE WAS NO INJURY TO PT OR TO THE OPERATOR REPORTED.
Additional Manufacturer Narrative
AFTER THE REPORT, THE CUSTOMER WAS INSTRUCTED TO REMOVE THE UNIT FROM USE AND SERVICE ENGINEER WAS DISPATCHED TO PERFORM EVALUATION AND REPAIR OF THE UNIT. THE ENGINEER CONFIRMED THE FAILURE, DETERMINED THAT THE FAILURE WAS CAUSED BY A DEFECTIVE PRINTED CIRCUIT BOARD. THE FIELD ENGINEER REPLACED THE BOARD AND VERIFIED PROPER OPERATION OF THE DEVICE. ONCE THE UNIT WAS REPAIRED IT WAS RETURNED TO CUSTOMER WAS USE.
Remedial action
- Repair