BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILON 6800

    MDR report key: 1756766 · Received June 30, 2010

    Report

    Report Number
    1125612-2010-00001
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 25, 2010
    Manufacturer
    DILON TECHNOLOGIES, INC.
    Product Code
    IYX
    PMA / PMN Number
    K984466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TECHNOLOGIST WAS PREPARING TO PERFORM AN AXILLA IMAGE ON A PATIENT SUPINE ON A GURNEY. WHILE POSITIONING THE DETECTOR NEAR THE PATIENT'S AXILLA, THE DETECTOR SEPARATED FROM ITS MOUNT, FALLING TO THE GURNEY. NEITHER THE PATIENT NOR THE TECHNOLOGIST WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILON 6800 CAMERA, SCINTILLATION (GAMMA) IYX DILON TECHNOLOGIES, INC. DILON 6800

    Patients

    Seq Age Sex Outcome Treatment
    1