BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIII BREAST IMAGING UNIT

    MDR report key: 16920 · Received October 18, 1994

    Report

    Report Number
    MW1003714
    Event Type
    Malfunction
    Date Received
    October 18, 1994
    Date of Event
    October 12, 1994
    Manufacturer
    LORAD MEDICAL SYSTEMS, INC.
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN EQUIPMENT MALFUNCTION OCCURRED WHICH RESULTED IN THE MACHINE GANTRY ELEVATING ON ITS OWN DURING THE COMPRESSION PROCESS. THE TOP CONTROL LOCATED ON THE LEFT SIDE OF THE MACHINE WAS USED TO ELEVATE THE MACHINE GANTRY. THIS WAS DONE TO ENSURE THE NIPPLE WAS IN PROFILE. WHILE ADJUSTING THE BREAST TISSUE, THE REGISTERED MAMMOGRAPHY TECHNOLOGIST USED THE FOOT PEDAL TO COMPRESS THE BREAST. AT THIS POINT, THE GANTRY ELEVATED SLIGHTLY ON ITS OWN. THE TECHNOLOGIST DEPRESSED THE BUTTON SEVERAL TIMES, THINKING THAT THE BUTTON MAY BE STICKING. MOVEMENT OF THE GANTRY STOPPED. THE PT'S BREAST WAS PLACED IN FULL COMPRESSION, AND THE REGISTERED MAMMOGRAPHY TECHNOLOGIST STEPPED AWAY FROM THE UNIT TO MAKE AN EXPOSURE. ONCE AGAIN, HOWEVER THE GANTRY CONTINUED TO ASCEND. THE PT'S BREAST WAS QUICKLY RELEASED FROM THE COMPRESSION BY THE REGISTERED MAMMOGRAPHY TECHNOLOGIST. CO REPLACED THE UNIT. AT THIS TIME, THE CAUSE OF THE MALFUNCTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIII BREAST IMAGING UNIT IZH LORAD MEDICAL SYSTEMS, INC. 3128K

    Patients

    Seq Age Sex Outcome Treatment
    1 *