BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 24905554 · Received April 16, 2026

    Report

    Report Number
    3019216-2026-100149
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 17, 2026
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    UDI-DI
    00884838123960
    PMA / PMN Number
    K132304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE EPIQ CVX ULTRASOUND SYSTEM WAS NOT AVAILABLE DURING A CRITICAL PROCEDURE. DURING AN OPEN HEART PROCEDURE, THE SYSTEM GENERATED ERROR CODES. THE ULTRASOUND SYSTEM WAS REBOOTED MULTIPLE TIMES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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
    80652 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