SYMBIA INTEVO BOLD

Description of Event or Problem

A COLLIMATOR CHANGE SEQUENCE WAS INITIATED WHILE THE PATIENT REMAINED POSITIONED ON THE IMAGING BED WITH THE HEAD SECURED. SYSTEM RECORDS INDICATE THAT THE COMMAND TO INITIATE THE SEQUENCE WAS ENTERED AT THE OPERATOR CONSOLE. THIS IS CONTRARY TO PRODUCT LABELING INSTRUCTIONS. DURING THE SEQUENCE, THE PATIENT WAS ADVANCED INTO THE COLLIMATOR BY APPROXIMATELY 16 MM (APPROXIMATELY 5/8 INCH). TOUCHPAD INPUTS WERE NOT EFFECTIVE IN STOPPING MOTION, AS TOUCHPAD FUNCTIONALITY IS DISABLED DURING AN ACTIVE COLLIMATOR CHANGE PER SYSTEM DESIGN. AN EMERGENCY STOP (E-STOP) WAS ACTIVATED, AND SYSTEM MOTION CEASED. PATIENT MOVEMENT WAS NOT POSSIBLE WHILE THE E-STOP CONDITION REMAINED ACTIVE. AFTER THE E-STOP CONDITION WAS CLEARED, THE PATIENT WAS REPOSITIONED USING THE HAND CONTROL, AND THE PATIENT WAS SUBSEQUENTLY RELEASED. A REVIEW OF SYSTEM LOG DATA INDICATES THAT THE DEVICE FUNCTIONED IN ACCORDANCE WITH ITS DESIGN, INCLUDING EXPECTED RESPONSES TO USER INPUTS AND SAFETY INTERLOCKS. NO DEVICE MALFUNCTION WAS IDENTIFIED. THERE WERE NO INJURIES TO ANY OTHER PERSONS. NO DEVICE OR LABELING DEFICIENCIES WERE IDENTIFIED.