BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23247841 · Received October 8, 2025

    Report

    Report Number
    3019216-2025-000350
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 8, 2025
    Report Date
    April 28, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR A PRODUCT ANALYSIS; HOWEVER, THE CUSTOMER DECLINED SERVICE AND SUPPORT. AS SUCH, THE TRANSDUCER COULD NOT BE OBTAINED FOR FAILURE ANALYSIS.

    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. THE ISSUE WAS DISCOVERED OUTSIDE OF CLINICAL USE AND THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER'S COMPLAINT WAS ADDRESSED BY INITIATING THE SERVICE PROCESS TO EVALUATE AND REPLACE THE TRANSDUCER, HOWEVER, THE CUSTOMER DECLINED SERVICE. 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
    20760 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown