BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIGNRT

    MDR report key: 4207054 · Received October 22, 2014

    Report

    Report Number
    3004832819-2014-00001
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 21, 2014
    Manufacturer
    VISION RT LTD
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISION RT'S INVESTIGATION ON THIS PROBLEM IS CURRENTLY IN PROGRESS AND HAS NOT YET REACHED A FINAL CONCLUSION AS TO THE ROOT CAUSE OF THE ISSUE.

    Description of Event or Problem · 1

    AFFECTED HARDWARE CONFIGURATION: VISION RT INTEGRATED GATE CONTROLLER (IGC-CS) WITH VARIAN MOTION MANAGEMENT INTERFACE (MMI) FOR C-SERIES. PLEASE NOTE THAT ONLY VISION RT'S RECENTLY INTRODUCED IGC-CS IS AFFECTED. PREVIOUS VERSIONS OF THE INTERFACE (VISION RT GATE CONTROLLER?GATE COMMANDER) ARE NOT AFFECTED. AFFECTED SOFTWARE VERSION: 5.0.1738 AND 5.0.1742 ONLY. THE ALIGNRT SYSTEM IS INDICATED FOR USE TO POSITION AND MONITOR PATIENTS POSITION, AND TO WITHHOLD THE BEAM AUTOMATICALLY DURING RADIATION DELIVERY. ALIGNRT IS ALSO USED TO TRACK THE PT RESPIRATORY PATTERN. WHEN PATIENT MOTION THAT EXCEEDS A PRE-SET TOLERANCE IS DETECTED BY ALIGNRT, IN RARE CIRCUMSTANCES AND ONLY FOR THE AFFECTED CONFIGURATION REFERENCED ABOVE, ALIGNRT WILL DISPLAY A WARNING MESSAGE ON THE MAIN MONITOR THAT STATES A BEAM HOLD INTERLOCK HAS BEEN ASSERTED, WHEN IN FACT NO INTERLOCK HAS ACTUALLY BEEN ASSERTED ON THE VARIAN MEDICAL SYSTEMS C-SERIES LINAC. INSTEAD, IN SUCH CIRCUMSTANCES, THE BEAM WILL REMAIN ENABLED. THE ISSUE IS READILY DETECTABLE BY THE USER FROM THE ALIGNRT USER INTERFACE (COMPUTER MONITOR) BECAUSE, IN ADDITIONAL TO THE WARNING MESSAGE, THE SYSTEM CORRECTLY SHOWS THAT THE GATE BEAM FUNCTIONALITY IS OFF, THAT THE BEAM IS CURRENTLY ENABLED, AND THAT THE REAL TIME DELTAS ARE OUT OF TOLERANCE. ADDITIONALLY, THE VARIAM MEDICAL SYSTEMS C-SERIES CONSOLE WILL PROVIDE VISIBLE AND AUDIBLE INDICATION OF THE ACTUAL STATUS OF THE BEAM. WHEN ALIGNRT DISPLAYS THIS MESSAGE, THE SOFTWARE MAY NO LONGER BE CONTROLLING BEAM DELIVERY ON THE C-SERIES LINAC. IF THE USER DOES NOT TAKE APPROPRIATE ACTION IN A TIMELY FASHION, THE ISSUE MAY LEAD TO THE DELIVERY OF A DOSE OF RADIATION TO AN UNINTENDED REGION OF THE PT. THE ISSUE WAS IDENTIFIED DURING NON-CLINICAL TESTING WHICH WAS PERFORMED TWO DAYS AFTER THE AFFECTED CONFIGURATION WAS FIRST USED FOR PT TREATMENT. THERE ARE NO REPORTS OF THE ISSUE HAVING OCCURRED ON PATIENTS. PLEASE NOTE THIS IS SUE CAN ONLY OCCUR WHEN ALIGNRT IS CONNECTED TO A VARIAN MEDICAL SYSTEMS C-SERIES LINEAR ACCELERATOR THROUGH THE MOTION MANAGEMENT INTERFACE (MMI). VISION RT HAS DISABLED THE MMI CONNECTION ON ALL AFFECTED SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672814 ALIGNRT PATIENT POSITIONING SYSTEM IYE VISION RT LTD ALIGNRT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA