BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVION S250I

    MDR report key: 10719879 · Received October 22, 2020

    Report

    Report Number
    3007087027-2020-00006
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 20, 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

    CUSTOMER REPORTED UPON INITIATION OF A TREATMENT BEAM, THE TREATMENT CONSOLE (TC) SCREEN UNEXPECTEDLY TERMINATED THE BEAM AND BLANKED OUT THE CURRENT FIELD DELIVERY INFORMATION. THE MONITOR UNIT (MU) COUNTER ON THE TOP RIGHT OF THE TC SCREEN CONTINUED TO INCREMENT UP, AND THE BEAM CONTROL BOX CONTINUED TO EMIT BEEPING SOUNDS CONSISTENT WITH BEAM DELIVERY. NO DICOM RECORD FOR THAT BEAM WAS CREATED OR SENT TO THE ONCOLOGY INFORMATION SYSTEM (OIS), AND THE RECORDS ACCESSIBLE TO THE USERS SHOWED NO DELIVERY OF DOSE TO THAT FIELD. THIS LEFT THE THERAPIST AND PHYSICIST UNCERTAIN AS TO HOW MUCH BEAM WAS DELIVERED. HAD THE USERS DECIDED TO DELIVER THE SAME BEAM AGAIN THE PATIENT COULD BE OVER TREATED. THE HARDWIRED MONITOR UNIT COUNTER (HMUC) LOCATED IN THE SYSTEM CABINET ACCURATELY CAPTURED THE DOSE DELIVERED BUT WAS NOT RECORDED BEFORE A SUBSEQUENT USER ACTION CLEARED THAT COUNTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185236 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