BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA MEDICAL IMAGING

    MDR report key: 20245808 · Received September 18, 2024

    Report

    Report Number
    20245808
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    May 27, 2024
    Report Date
    May 29, 2024
    Manufacturer
    OMEGA MEDICAL IMAGING, LLC
    Product Code
    MQB
    UDI-DI
    00853901007001
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FLUOROSCOPY ERCP BILIARY ORDER DID NOT TRANSFER TO OMEGA WORKLIST AFTER PRESSING THE QUERY BUTTON. SAMSUNG IPAD WOULD NOT CONNECT TO WI-FI AND SMALL MONITOR ON THE RIGHT TO THE 2 COMPUTERS WOULD NOT TURN ON. ATTEMPTED TO SHUT DOWN AND TURN SYSTEM DOWN MULTIPLE TIMES BUT THE SAME ISSUES AS STATED ABOVE STILL HAPPENED. MANUALLY PUT PT'S NAME, DOB, AND MR NUMBER. MD TESTED FLUORO AND IT WORKED BUT UNABLE TO SAVE PICTURES AND NO ACCESSION NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384513 OMEGA MEDICAL IMAGING SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB OMEGA MEDICAL IMAGING, LLC CS50 00853901007001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male