BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSION MAMMOGRAPHY SYSTEM 3D

    MDR report key: 3896353 · Received May 20, 2014

    Report

    Report Number
    1220984-2014-00004
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOLOGIC INC
    Product Code
    OTE
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOLOGIC FIELD ENGINEER WENT TO THE SITE ON (B)(4) 2014 AND FOUND THEM USING A ROLLING X-RAY SHIELD. THE BROKEN PIECES OF GLASS THAT HAD COME FROM THE SELENIA DIMENSIONS SYSTEM HAD ALREADY BEEN DISCARDED, SO THERE WAS NOTHING AVAILABLE TO EXAMINE. THERE WAS NO REPORT OF ANYONE BUMPING OR OTHERWISE DAMAGING THE SHIELD. THE FIELD ENGINEER REPLACED THE X-RAY SHIELD. THE X-RAY SHIELD PROVIDED WITH THE SELENIA DIMENSIONS SYSTEM IS MADE OF TEMPERED GLASS (SAFETY GLASS), SO AS NOT TO CAUSE HARM IF THE GLASS IS BROKEN. THIS PARTICULAR LOT OF GLASS WAS PREVIOUSLY EVALUATED AND DETERMINED TO MEET THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE TECHNOLOGIST LEFT FOR THE DAY AND WHEN THEY RETURNED FOUND THE X-RAY SHIELD ON THE SELENIA DIMENSIONS SYSTEM HAD SHATTERED. IT HAD BEEN CLEANED UP BY THE TIME THE TECHNOLOGIST RETURNED, SO THEY COULD NOT DESCRIBE THE CIRCUMSTANCES REGARDING WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300828 SELENIA DIMENSION MAMMOGRAPHY SYSTEM 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC INC SDM-00001-3D NA

    Patients

    Seq Age Sex Outcome Treatment
    1