BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVID IQ

    MDR report key: 19358230 · Received May 21, 2024

    Report

    Report Number
    19358230
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    February 16, 2024
    Report Date
    April 1, 2024
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
    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

    ULTRASOUND CATHETER INSERTED, BUT PROCEDURE DELAYED WHILE TROUBLE-SHOOTING MULTIPLE ULTRASOUND CONSOLE ERRORS. PATIENT INTUBATED AND UNDER GENERAL ANESTHESIA. PROVIDER UNABLE TO SEE ULTRASOUND IMAGE ON LARGE SCREEN SO VISUALIZING ON SMALL CONSOLE SCREEN WITH SUBOPTIMAL RESOLUTION. UNABLE TO TRANSMIT TO 3D IMAGE TO MAPPING SYSTEM TO BE UTILIZED WITH THE CARTOSOUND SOFTWARE PURCHASED FOR OPTIMAL PATIENT OUTCOMES. BIOMED CALLED MULTIPLE TIMES A WEEK TO TROUBLESHOOT NUMEROUS AND VARIED ISSUES WITH 2 VIVIDI IQ AND S70 CONSOLES. LAST INCIDENT PRIOR TO TODAY WAS [DATE REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155242 VIVID IQ SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 569592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male