THE CUSTOMER REPORTED, "A PLAN IS CREATED ON THE CT DATASET OF THE PT IN A CERTAIN RESPIRATORY PHASE (DEEP INSPIRATION BREATH HOLD IN OUR CASE). THE TOGGLE "USE GATED" IN THE GENERAL TAB OF THE PLAN PROPERTIES (IN ECLIPSE OR EVEN IN RT-CHART) IS ON. THE PLAN IS LOADED IN THE 4D ITC. IF THE KEY OF THE RPM SYSTEM (THE BOX ENABLING THE USAGE OF THE GATING SYSTEM) IS IN THE POSITION GATING DISABLED, THE PLAN IS TREATABLE! IN OTHER WORDS, THERE IS NO INTERLOCK PREVENTING THE IRRADIATION OF THE PLAN SUPPOSED WITH GATING (AS PER THE TOGGLE "USE GATED"). A PT WAS MIS-ADMINISTERED."
N
Patient 1
OTHER: BASED ON THE INITIAL REPORT, VARIAN'S MEDICAL ADVISOR WAS NOT ABLE TO RENDER A MEDICAL EVALUATION ON WHETHER THIS EVENT MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, OR WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.