BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA HD

    MDR report key: 21632534 · Received March 18, 2025

    Report

    Report Number
    3015232217-2025-00003
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 18, 2025
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    05060191071574
    PMA / PMN Number
    K210500
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCTS AND THE REPORTED INFORMATION. THE CUSTOMER WAS DELIVERING A STEP AND SHOOT IMRT. THE LINEAR ACCELERATOR STARTED TO RADIATE WHILST THE MLC (MULTI LEAF COLLIMATOR) WAS STILL MOVING TO THE NEXT POSITION AND BEFORE THE MLC HAD REACHED THE EXPECTED POSITION. THEREFORE IT WOULD BE POSSIBLE TO DELIVER SEVERAL MUS (MONITOR UNITS) WITH THE MLC SHAPE NOT IN ITS FINAL POSITION, TO BODY PARTS WHICH WERE NOT EXPECTED TO RECEIVE RADIATION DOSE. THE INTEGRITY SYSTEM HAS AN INTERLOCK TO INTERRUPT OR TERMINATE THE BEAM IF ANY DOSE IS DETECTED BY THE MONITORING SYSTEM WHEN NO IRRADIATION IS EXPECTED (IN THIS CASE, DURING A BEAM ONLY SEGMENT). IN THIS CASE THE DELIVERY WAS TERMINATED BY PRF CONTROL ERROR (ITEM 7070). THE MACHINE BEHAVED AS INTENDED AND TERMINATED THE BEAM WITHIN A DEFINED TIME WHEN THE MACHINE PARAMETERS DID NOT BEHAVE AS EXPECTED. ON (B)(6) 2025, 1 PATIENT WAS AFFECTED BY THIS ISSUE AND 7MU WERE DELIVERED WHEN THE MLC WAS NOT IN THE CORRECT POSITION. THE CUSTOMER DID 4 TO 5 RESETS TO COMPLETE THE PATIENT TREATMENT, SO A TOTAL OF APPROXIMATELY 35MU WERE DELIVERED. THIS HAS BEEN ASSESSED AS AN OVERDOSE OF 0.35GY AND RESULTED IN MORE THAN 5% OF THE INTENDED DOSE. THIS IS CONSIDERED A SERIOUS MISTREATMENT. THE INVESTIGATION FOUND THAT THE ROOT CAUSE OF THIS ISSUE WAS DUE TO A FAULTY SERIAL LINK CABLE, WHICH WAS CAUSING THE BEAM TO START BEFORE THE MLC HAD REACHED ITS FINAL POSITION. THE CONNECTOR WAS REPAIRED AND THE MACHINE TESTED, THIS RESOLVED THE ISSUE. ELEKTA PERFORMED A RISK ASSESSMENT AND ASSESSED THE SEVERITY OF HARM TO BE "SERIOUS" AND PROBABILITY TO BE "INCREDIBLE". THE RISK ASSESSMENT CONCLUDED THAT THE RISK IS CONSIDERED LOW.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN DELIVERING STEP AND SHOOT IMRT BEAMS ON THIS MACHINE, THE BEAM STARTED PRIOR TO THE MLC LEAVES BEING IN THEIR FINAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212456 VERSA HD ACCELERATOR, LINEAR, MEDICAL, IYE 05060191071574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other