BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC DHX

    MDR report key: 1250875 · Received December 1, 2008

    Report

    Report Number
    2916710-2008-00045
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN INVESTIGATING THE NOISE, IT WAS IDENTIFIED THAT ONE OF THE BOLTS THAT HOLDS THE COUNTER WEIGHT (CWT) IN PLACE WAS LOOSE. THE BOLT WAS PLACED BACK INTO POSITION AND TIGHTENED. THE INVESTIGATION REVEALED THAT VARIAN'S CONTRACT RIGGING COMPANY DID NOT TIGHTEN THE BOLT PROPERLY WHEN THE COUNTER WEIGHT WAS INSTALLED. IF COUNTER WEIGHT BOLTS ARE NOT TIGHTENED CORRECTLY, THE BOLTS CAN SUFFER FATIGUE FAILURE, RESULTING IN CWT/GANTRY SEPARATION OR SEVERE GANTRY IMBALANCE. VARIAN'S FIELD SERVICE PERSONNEL VISITED THE USER SITE AND REPLACED ALL THE BOLTS ORIGINALLY INSTALLED BY THE RIGGING COMPANY. THE ISSUE WILL BE ADDRESSED FURTHER IN THE CAPA SYSTEM. NO FOLLOW-UP REPORTS ARE ANTICIPATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER THAT NOISE WAS COMING FROM INSIDE THE GANTRY. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC DHX ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS CL2300

    Patients

    Seq Age Sex Outcome Treatment
    1