BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23280986 · Received October 15, 2025

    Report

    Report Number
    3019216-2025-000358
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    May 5, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838123960
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE ENGINEER REPLACED THE S7-3T TRANSDUCER TO ADDRESS THE CUSTOMER'S IMMEDIATE CONCERNS. A THOROUGH INVESTIGATION WAS PERFORMED TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. THE TRANSDUCER WAS EVALUATED, AND THE REPORTED ISSUE WAS UNABLE TO BE REPRODUCED. THE TRANSDUCER PASSED ALL ELECTRICAL SAFETY TESTS. THE SYSTEM HAS RETURNED TO SERVICE WITH NO SIMILAR ISSUES REPORTED POST REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE S7-3T TRANSDUCER FAILED ELECTRICAL LEAKAGE TESTING. 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. SERVICE HAS BEEN INITIATED TO EVALUATE AND REPLACE THE TRANSDUCER TO ADDRESS 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
    193718 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