BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM

    MDR report key: 23284969 · Received October 15, 2025

    Report

    Report Number
    3019216-2025-000359
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    March 20, 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
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A QUALIFIED FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND WAS UNABLE TO REPRODUCE THE REPORTED IMAGE ARTIFACT. THE ULTRASOUND SYSTEM WAS RETURNED FOR FURTHER EVALUATION. THE ENGINEERING TEAM ALSO COULD NOT REPLICATE THE REPORTED IMAGE ARTIFACT AS DESCRIBED BY THE CUSTOMER. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE THE REQUESTED DETAILS. THE REPORTED CONCERN WAS INITIALLY REPORTED AS A PRODUCT PROBLEM BECAUSE THERE WAS NO INDICATION OF A SERIOUS INJURY. HOWEVER WE ARE CONSERVATIVELY SUBMITTING THIS FINAL REPORT AS A SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED PROCEDURE IN THE CARDIOVASCULAR OPERATING ROOM WAS UNABLE TO BE COMPLETED ON THE EPIQ CVX ULTRASOUND SYSTEM DUE TO AN IMAGE ARTIFACT. THE USER EXCHANGED THE ULTRASOUND SYSTEM TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION IS BEING OBTAINED TO DETERMINE PATIENT IMPACT. 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
    55590 EPIQ CVX DIAGNOSTIC ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC 00884838123960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown