BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSITE LX ULTRASOUND SYSTEM

    MDR report key: 23933227 · Received December 31, 2025

    Report

    Report Number
    23933227
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    October 6, 2025
    Report Date
    October 10, 2025
    Manufacturer
    FUJIFILM SONOSITE, INC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAVE HAD MULTIPLE INSTANCES OF THE FOLLOWING ISSUES: CONTROLS ON LCD SCREEN FREEZE, HAVE TO RE-START MULTIPLE TIMES. MACHINE FREEZES WHILE TAKING PHOTOS. MACHINE NOT UPDATING WITH PATIENT INFORMATION. IMAGE GOING BLACK WHEN THERE IS A NEEDLE IN PATIENTS' NECKS. NO SOUND WHEN THE MACHINE IS PLUGGED INTO COMPUTER. OF NOTE: OUR BIOMEDICAL DEPARTMENT HAS NOTED THAT THE COMPANY MENTIONED HAVING "BUGS" IN THE SYSTEM. MANUFACTURER RESPONSE FOR ULTRASOUND MACHINE, SONOSITE LX ULTRASOUND SYSTEM (PER SITE REPORTER). NOT RESPONSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462419 SONOSITE LX ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN FUJIFILM SONOSITE, INC. SONOSITE LX, L28354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown