BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23705631 · Received December 3, 2025

    Report

    Report Number
    3019216-2025-000457
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 6, 2025
    Report Date
    January 13, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838107526
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALIFIED FIELD SERVICE ENGINEER EVALUATED THE SYSTEM BASED ON THE CUSTOMER COMPLAINT. THE CUSTOMER'S COMPLAINT WAS ADDRESSED BY REPLACING SOLENOID. AFTER REPLACING THE SOLENOID, THE SYSTEM PASSED TESTING, AND NO ADDITIONAL REPAIR OR ANALYSIS ACTION WAS REQUIRED. THE SOLENOID WAS DISPOSED OF IN THE FIELD BY THE FIELD SERVICE ENGINEER. THE SYSTEM HAS BEEN RETURNED TO SERVICE AND NO FURTHER ISSUES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SWIVEL MECHANISM OF THE EPIQ CVX ULTRASOUND SYSTEM¿S CONTROL PANEL DID NOT LOCK PROPERLY WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. THE FAILURE OCCURRED OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE SOLENOID 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
    2821888 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