BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23415676 · Received October 29, 2025

    Report

    Report Number
    3019216-2025-000400
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 1, 2025
    Report Date
    March 12, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATED THE RETURNED TRANSDUCER AND CONCLUDED THE TRANSDUCER WAS REPAIRED BY A THIRD PARTY. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT TRANSDUCER TO ADDRESS THEIR IMMEDIATE CONCERNS. AS THE TRANSDUCER WAS REPAIRED BY A THIRD PARTY, NO FURTHER INVESTIGATION COULD BE PERFORMED. NO FURTHER SIMILAR ISSUES HAVE BEEN REPORTED FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE X8-2T TRANSDUCER FAILED ELECTRICAL LEAKAGE TESTING. THE TRANSDUCER WAS ASSOCIATED WITH THE EPIQ CVX ULTRASOUND SYSTEM AT THE CUSTOMER¿S SITE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT TRANSDUCER TO ADDRESS THEIR IMMEDIATE 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
    2719176 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