BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23481872 · Received November 5, 2025

    Report

    Report Number
    3019216-2025-000422
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 7, 2025
    Report Date
    May 27, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838123960
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM BASED ON THE CUSTOMER COMPLAINT AND CONFIRMED THE ISSUE. THE FSE REPLACED THE SOLID STATE DRIVE (SSD) AND REINSTALLED THE SOFTWARE TO ADDRESS THE CUSTOMER'S IMMEDIATE CONCERNS. NO FURTHER INFORMATION IS AVAILABLE. THERE HAVE BEEN NO SIMILAR ISSUES SUBSEQUENT TO THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT THEIR EPIQ CVX ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL HEART VALVE PROCEDURE. THE SYSTEM GENERATED AN ERROR CODE, AND THE ISSUE PERSISTED AFTER A REBOOT. THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WAS NO PATIENT OR USER HARM AS A RESULT OF THE ISSUE. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE SSD (SOLID-STATE DRIVE) AND RELOADED THE SYSTEM SOFTWARE 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
    255548 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 795231 00884838123960

    Patients

    Seq Age Sex Outcome Treatment
    1