BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 192494 · Received October 20, 1998

    Report

    Report Number
    MW1014778
    Event Type
    Malfunction
    Date Received
    October 20, 1998
    Date of Event
    October 15, 1998
    Report Date
    October 19, 1998
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHILE TREATING A PROSTATE CANCER PT VIA BILATERAL ROTATIONAL ARC ON A VARIAN 2100C/D, THE VARIS SYSTEM DID NOT RECORD BOTH LATERAL ARC TREATMENTS. ONLY ONE TREATMENT FOR THE RIGHT LATERAL WAS RECORDED INTO THE VARIS SYSTEM ALTHOUGH BOTH SIDES WERE TREATED. THE ERROR WAS NOTED AND THE TREATMENT FOR THE LEFT LATERAL WAS INPUT MANUALLY. THE RIGHT CLOCKWISE ARC WAS TREATED AND STAFF WERE GOING TO TREAT THE LEFT LATERAL ARC. THE TREATMENT WAS GIVEN, BUT THEN VARIS SAID IT WASN'T. THE GANTRY WAS AT 30 DEGREES AND THE CORRECT MILLI-UNITS WERE GIVEN ACCORDING TO THE CONSULE, BUT WHEN STAFF PRINTED OUT THE LEFT LATERAL AND WASN'T RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * IYE VARIAN ASSOC., INC. * NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO