INTELLI-C

Additional Manufacturer Narrative

FROM PHOTOS RECEIVED FROM SITE, WE CAN CLEARLY SEE THAT THE DRIVE SHAFT IS BROKEN. A NEW DRIVE SHAFT HAS BEEN INSTALLED ON SITE, AND THE PARTS INVOLVED IN THE EVENT ARE BEING TRANSPORTED TO NRT FOR INVESTIGATION. ONCE RECEIVED, THE PARTS WILL UNDERGO METALLURGIC ANALYSIS TO ESTABLISH THE ROOT CAUSE OF THE EVENT.

Description of Event or Problem

DURING AN EXAMINATION OF A PATIENT, IT WAS FOUND THAT A DRIVE SHAFT IN THE IDE MOVEMENT OF THE INTELLI-C X-RAY DEVICE HAD BROKEN. THE IDE MOVEMENT THAT DRIVES THE DETECTOR INTO POSITION, MOVED UNTIL IT WAS STOPPED BY THE MOVEMENT END STOP. THE EVENT DID NOT CAUSE ANY INJURY TO PATIENT OR OPERATOR AS NO ONE WAS HIT BY THE UNINTENDED MOVEMENT.