BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC SELENIA

    MDR report key: 3131163 · Received May 22, 2013

    Report

    Report Number
    MW5030284
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 22, 2013
    Manufacturer
    HOLOGIC
    Product Code
    IZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE HOLOGIC SELENIA IN MAMMOGRAPHY ROOM 2, THE MOTOR W CONTINUED TO ENGAGE AFTER THE FOOT PEDAL WAS RELEASED. HELD FINE TUNE HANDLE TO TRY TO RELEASE, VERY DIFFICULT TO TURN. WAS ABLE TO RELEASE THE PADDLE. PT WAS SORE, BUT NOT HURT, NO INJURY VISIBLE. SERVICE WAS CONTACTED, AND COULD FIND NO PROBLEM WITH MACHINE. IF THIS HAPPENS AGAIN, INSTRUCTED TO USE EMERGENCY BUTTON GANTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226583 HOLOGIC SELENIA MAMMOGRAPHY MACHINE IZH HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1