BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23206285 · Received October 2, 2025

    Report

    Report Number
    3019216-2025-000348
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 3, 2025
    Report Date
    February 4, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALIFIED FIELD SERVICE ENGINEER CONFIRMED THE REPORTED ISSUE AND REPLACED THE TRANSDUCER TO RESOLVE THE CUSTOMER'S IMMEDIATE CONCERNS. AN INVESTIGATION WAS PERFORMED WHICH DETERMINED THE TRANSDUCER FAILED THE ELECTRICAL LEAKAGE TESTING AS A RESULT OF ACCIDENTAL USER DAMAGE. THERE WAS NO INDICATION OF EITHER NON-CONFORMING MATERIAL AND NO INDICATION OF DESIGN ANOMALY REQUIRING FURTHER ACTION. THE DEVICE HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED.

    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. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE TRANSDUCER TO RESOLVE THE CUSTOMER¿S 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
    277832 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown