BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELENIA MAMMOGRAPHY SYSTEM

    MDR report key: 7865828 · Received September 11, 2018

    Report

    Report Number
    1220984-2018-00148
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    August 14, 2018
    Report Date
    August 14, 2018
    Manufacturer
    HOLOGIC, INC
    Product Code
    MUE
    PMA / PMN Number
    P010025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE C-ARM MOVED UN-COMMANDED WHEN IN THE MLO POSITION. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND WAS UNABLE TO DUPLICATE THE ISSUE, BUT NOTED A "GREASE BLOB" ON THE MOTOR AND LAMP CONTROL BOARD NEAR THE CONNECTOR FOR C-ARM ROTATION. THE GREASE WAS CLEANED FROM THE BOARD AND THE SYSTEM WAS TESTED. ONCE THIS WAS COMPLETED THE SYSTEM WAS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704595 SELENIA MAMMOGRAPHY SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE HOLOGIC, INC SEL-00013

    Patients

    Seq Age Sex Outcome Treatment
    1