BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVION S250I

    MDR report key: 10787991 · Received November 4, 2020

    Report

    Report Number
    3007087027-2020-00007
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MEVION MEDICAL SYSTEMS, INC.
    Product Code
    LHN
    UDI-DI
    00864366000124
    PMA / PMN Number
    K172848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN THE EVENT THAT A USER ACTION CAUSES ISOCENTER TO BE LOST DURING THE SETUP WORKFLOW, THE SYSTEM WILL PRESENT ERROR MESSAGES ON THE IN-ROOM MONITOR AND THE TC SCREEN INDICATING THAT DELTAS WERE NOT APPLIED DURING SETUP OR A PROGRAM MOVE COMPLETE (PMC) WAS NOT ACHIEVED. WHEN THE SETUP FIELD IS CLOSED ANOTHER ERROR MESSAGE APPEARS ON THE TC THAT INFORMS THE USER OF A PROBLEM, WHICH THEY MUST CORRECT. THE USER IS PREVENTED FROM PROCEEDING TO A TREATMENT FIELD UNTIL THE SETUP IS CORRECTED AND THE SETUP FIELD IS CLOSED WITH A PMC. THE AUTO-FIELD SEQUENCING OPTION AS CURRENTLY IMPLEMENTED, AUTOMATICALLY LOADS THE FIRST TREATMENT FIELD AFTER THE ABOVE ERROR MESSAGE IS ACKNOWLEDGED. THE WORKFLOW IS PERMITTED TO PROCEED TO TREATMENT. ADDITIONAL WARNINGS WILL APPEAR BEFORE EACH BEAM CAN BE TURNED ON, BUT THOSE WARNINGS MAY BE IMPROPERLY IGNORED. IF THE INCOMPLETE MOVE AND LOST ISOCENTER PUTS THE PATIENT A SIGNIFICANT DISTANCE AWAY FROM THE PRESCRIBED POSITION, A MISADMINISTRATION DUE TO A GEOGRAPHIC MISS IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248592 MEVION S250I MEVION PROTON RADIATION THERAPY SYSTEM LHN MEVION MEDICAL SYSTEMS, INC. MEVION S250I N/A 00864366000124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other