BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID

    MDR report key: 22104369 · Received May 29, 2025

    Report

    Report Number
    22104369
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 20, 2025
    Report Date
    May 21, 2025
    Manufacturer
    G E MEDICAL SYSTEMS ISRAEL LTD.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A STRESS ECHO, THE MACHINE GAVE AN ERROR MESSAGE THEN SHUT OFF. HAD TO KEEP THE PATIENT'S HR [HEART RATE] UP WHILE REBOOTING THE MACHINE. MANUFACTURER RESPONSE FOR ULTRASOUND, S70 (PER SITE REPORTER). GE SERVICE REPRESENTATIVE ON SITE [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710849 VIVID SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN G E MEDICAL SYSTEMS ISRAEL LTD. S70

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male