INGENIA

Description of Event or Problem

PHILIPS RECEIVED A REPORT THAT DURING THE SCAN, ARTIFACTS WERE PRESENT, DETERMINED TO BE CAUSED BY A FAILURE IN THE CONNECTIONS BETWEEN THE GRADIENT COIL TERMINALS AND THE BUS BARS. THERE WAS ALSO VISIBLE HEAT DAMAGE AT THE CONNECTION AND THE OVERLAYING SYSTEM COVER. NO PATIENTS OR USERS WERE HARMED BY THIS MALFUNCTION AND THERE WAS NO REPORT OF SMOKE OR A BURNING SMELL. IN LIGHT OF PREVIOUS GRADIENT COIL CONNECTION FAILURES THAT HAVE LED TO SUBSTANTIAL DAMAGE TO MR SYSTEMS AND HOSPITAL PROPERTY AND THE FACT THAT THE CAUSE OF THE FAILURE IS OF YET UNKNOWN WE HAVE DECIDED, OUT OF AN ABUNDANCE OF CAUTION, TO REPORT THIS MALFUNCTION.

Additional Manufacturer Narrative

PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.