BEUDAMED
    FDA Adverse Event Summary report: N

    RECORD AND VERIFY SYSTEM

    MDR report key: 11025 · Received January 24, 1994

    Report

    Report Number
    MW1000463
    Date Received
    January 24, 1994
    Report Date
    January 13, 1994
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    IYE
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    DURING A POWER INTERRUPT TO THE ATTACHED ACCELERATOR, THE DEVICE RECORDED THAT 999 MU'S WERE DELIVERED WHEN ONLY 3 MU'S WERE ACTUALLY DELIVERED. THE ACCELERATOR IS ANALOG BASED. THE MECHANICAL COUNTER RECORDED 3 MU'S. THE PROBLEM IS REPEATABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECORD AND VERIFY SYSTEM IYE VARIAN ASSOC., INC. RMS-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 *