BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

    MDR report key: 8587903 · Received May 7, 2019

    Report

    Report Number
    1220984-2019-00047
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 17, 2019
    Manufacturer
    HOLOGIC, INC
    Product Code
    OTE
    UDI-DI
    15420045505636
    PMA / PMN Number
    P080003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS NOTED THAT THE CUSTOMER HAD REBOOTED THE SYSTEM WHICH RESOLVED THE ISSUE. THE SYSTEM WAS MONITORED AND ON FOLLOW UP THE ISSUE HAD NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE INVESTIGATION IS STILL IN PROCESS AND A FOLLOW UP WILL BE FILED AS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO ROTATE TO THE MLO POSITION, THE MACHINE DOES NOT STOP AT THE 45 DEGREE ANGLE. INSTEAD THE C-ARM WOULD CONTINUE TO ROTATE UNPROMPTED. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380193 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D MAMMOGRAPHY SYSTEM OTE HOLOGIC, INC SDM-SYS-9000-3D 15420045505636

    Patients

    Seq Age Sex Outcome Treatment
    1