IC PROFILER-MR

Description of Event or Problem

STAFF USING AN IC PROFILER-MR AT (B)(6) RADIATION ONCOLOGY REPORTED THEIR IC PROFILER-MR UNIT THAT WAS RESTING ON THE COUCH MOVED WHEN THE COUCH WAS TRANSLATED INTO A MAGNETIC FIELD OF A VIEWRAY DELIVERY SYSTEM. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

THE IC PROFILER-MR IS NOT USED IN THE PRESENCE OF A PATIENT. HOWEVER, STAFF SETTING UP THE IC PROFILER-MR FOR MEASUREMENT OF AN INSTALLED VIEWRAY DELIVERY SYSTEM COULD EXPERIENCE A PINCH HAZARD BETWEEN THE COVERS ON THE DELIVERY SYSTEM AND THE IC PROFILER-MR IF IT IS ATTRACTED TOWARDS THE DELIVERY SYSTEM BY THE MAGNETIC FIELD. INVESTIGATION IDENTIFIED AN ASSEMBLY ERROR OF THIS UNIT. THERE WERE 3 UNITS MANUFACTURED IN THE LOT AND 9 UNITS MANUFACTURED IN TOTAL. AS PART OF THE INVESTIGATION OF THIS INCIDENT, ALL UNITS MANUFACTURED HAVE BEEN EVALUATED. DATA OBTAINED CONFIRMED 2 UNITS CONTAINED THE ASSEMBLY ERROR. THESE UNITS HAVE BEEN REMOVED AND REPAIRED.