BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23846039 · Received December 18, 2025

    Report

    Report Number
    3019216-2025-000494
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 18, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSESOPHAGEAL X8-2T TRANSDUCER¿S SEALANT ON THE TIP WAS COMING OFF. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE PHILIPS SERVICE ENGINEER REPLACED THE TRANSDUCER TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. 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
    258784 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231 00884838107526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown