BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVATRON MDX LINEAR ACCELERATOR

    MDR report key: 14775 · Received July 20, 1994

    Report

    Report Number
    MW1002885
    Event Type
    Malfunction
    Date Received
    July 20, 1994
    Report Date
    July 19, 1994
    Manufacturer
    SIEMENS MEDICAL LABORATORIES, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT, THE RADIATION FIELD SIZE CHANGED. THE RECORD AND VERIFY SYSTEM TURNED THE ACCELERATOR OFF. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEVATRON MDX LINEAR ACCELERATOR LINEAR ACCELERATOR IYE SIEMENS MEDICAL LABORATORIES, INC. MDX

    Patients

    Seq Age Sex Outcome Treatment
    1 *