BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN CLINAC

    MDR report key: 241812 · Received September 20, 1999

    Report

    Report Number
    MW1017223
    Event Type
    Malfunction
    Date Received
    September 20, 1999
    Report Date
    September 15, 1999
    Manufacturer
    VARIAN ASSOC, INC.
    Product Code
    JAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON ROTATION OF THE TREATMENT COUCH ON ITS BASE A CRACKING NOISE WAS HEARD EMITTED FROM THE BASE OF THE TREATMENT COUCH. INVESTIGATION REVEALED ALL BUT ONE OF THE BOLTS WHICH SECURED THE TREATMENT COUCH TO THE BASE HAD BECOME SHEARED OFF. THIS ALLOWED THE TREATMENT COUCH TO TIP DOWNWARD TOWARD THE GANTRY AND STAND WHEN THE TABLE WAS EXTENDED TOWARD THE ACCELERATOR WITH A PT IN PLACE. THE RESULT WOULD BE MISALIGNMENT OF THE PT AT THE ISOCENTER BY APPROX 2 CM (ESTIMATED). PT TREATMENTS WERE DISCONTINUED, AND REPAIR OF THE UNIT REQUIRED RIGGERS TO REMOVE THE COUCH FROM THE FLOOR AND BASE, REPLACE ALL THE SHEARED BOLTS AND STAND-OFFS, AND RE-ESTABLISH ISOCENTER. OPERATION APPEARS TO BE NORMAL SINCE THE TIME OF THAT REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN CLINAC TREATMENT COUCH JAI VARIAN ASSOC, INC. 2100C/D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other