BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23297706 · Received October 15, 2025

    Report

    Report Number
    3019216-2025-000362
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 15, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838123960
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THEIR EPIQ CVX ULTRASOUND SYSTEM FROZE THEN SHUTDOWN DURING A CABG (CORONARY ARTERY BYPASS GRAFT). THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE. THERE WAS NO USER OR PATIENT HARM AS A RESULT OF THE ISSUE. PHILIPS HAS INITIATED ONSITE SERVICE TO ADDRESS THE CUSTOMER¿S CONCERNS. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021156 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231 00884838123960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown