BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA MEDICAL IMAGING

    MDR report key: 20299902 · Received September 25, 2024

    Report

    Report Number
    20299902
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    June 22, 2024
    Report Date
    June 27, 2024
    Manufacturer
    OMEGA MEDICAL IMAGING, LLC
    Product Code
    MQB
    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 WAS WORKING BUT WAS UNABLE TO SAVE PICTURES. TRIED TO TURN OMEGA SYSTEM OFF AND ON BUT WAS UNSUCCESSFUL (COMPUTER WOULD NOT TURN BACK ON). REBOOTED ENTIRE OMEGA SYSTEM BY FLIPPING THE SWITCH IN THE LARGE EQUIPMENT CLOSET IN ROOM 5 NEXT TO THE COMPUTERS. IT TOOK SEVERAL MINUTES TO REBOOT BUT ONCE REBOOTED, FLUOROSCOPY WAS WORKING AS WELL AS THE ABILITY TO SAVE PICTURES. OMEGA EQUIPMENT WAS BEEPING THROUGHOUT THE PROCEDURE AND AFTER PROCEDURE AFTER OMEGA SYSTEM WAS SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239324 OMEGA MEDICAL IMAGING SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) MQB OMEGA MEDICAL IMAGING, LLC CS50

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other