BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2031489 · Received March 18, 2011

    Report

    Report Number
    2916710-2011-00024
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS THAT THERE MAY BE POTENTIAL FOR MALFUNCTION OF VARIAN DEVICES WHICH UTILIZE THESE SHEET METAL COMPONENTS. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE AS THIS POTENTIAL FOR MALFUNCTION, SHOULD IT OCCUR IN A VARIAN DEVICE, COULD POTENTIALLY CAUSE SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING TEST IN THE VARIAN MANUFACTURING ASSEMBLY AREA, INTERMITTENT ARCING ON A MODULATOR (A DEVICE COMPONENT) WAS OBSERVED. THE SHEET METAL COMPONENTS USED WERE FOUND TO HAVE A GOLD ANODIZED PLATING, HOWEVER, THE BRACKETS AND SHEET METAL COMPONENTS ARE SPECIFIED TO HAVE A GOLD ALODINE PLATING. ANODIZE IS NONCONDUCTIVE WHICH WILL PREVENT PROPER GROUNDING/ELECTRICAL CONNECTION. THIS COULD POTENTIALLY LEAD TO AN ELECTRICAL HAZARD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1