BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOZART 3D SPECIMEN TOMOSYNTHESIS

    MDR report key: 16214026 · Received January 20, 2023

    Report

    Report Number
    3006051164-2023-00001
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    September 21, 2022
    Report Date
    January 20, 2023
    Manufacturer
    KUB TECHNOLOGIES, INC
    Product Code
    MWP
    UDI-DI
    B619X420
    PMA / PMN Number
    K210956
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS TO ACKNOWLEDGE RECEIPT OF THE MEDWATCH REPORT SENT BY FDA THAT WAS ORIGINATED BY A HEALTCHARE FACILITY. THE DEVICE HAD BEEN INSTALLED AND LEFT AT THE FACILITY MEETING ALL INSTALLATION REQUIREMENTS WITH THE AUTOMATED UPDATE FUNCTION TURNED OFF. THE CUSTOMER WAS INFORMED IN PAST TO WORK WITH THEIR IT DEPARTMENT AND LEAVE THE AUTOMATED UPDATE FUNCTION OFF AND HAVE UPDATES PERFORMED WHEN EQUIPMENT IS NOT IN USE. KUBTEC IS WORKING WITH THE CUSTOMER TO ENSURE ORIGINAL SETTINGS ARE MAINTAINED TO AVOID AUTOMATIC UPDATES FROM OCCURRING DURING USAGE.

    Description of Event or Problem · 0

    THE COMPANY RECEIVED A MEDWATCH REPORT FROM FDA ON 12/30/2022 THAT WAS FILED BY A HEALTHCARE FACILITY. THE REPORT (# MW5113921) ALLEGED THAT THERE WERE PROBLEMS WITH THE MOZART XPERT 42 SYSTEM DURING SURGICAL CASES. THE REPORT ALLEGED THAT THE SYSTEM STARTED PERFORMING AN AUTOMATIC UPDATE DURING USE RESULTING IN THE SCREENS GOING BLACK, LOSS OF IMAGING AND INABILITY TO IDENTIFY THE LOCATION OF IMPLANTED TISSUE MARKER CLIPS. AS A RESULT THE PATIENT HAD TO RETURN TO HAVE A SECOND SURGERY TO REMOVE CANCEROUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364475 MOZART 3D SPECIMEN TOMOSYNTHESIS CABINET- X-RAY SYSTEM MWP KUB TECHNOLOGIES, INC XPERT42 B619X420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention