BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIQ CVX

    MDR report key: 21845068 · Received April 15, 2025

    Report

    Report Number
    3019216-2025-000176
    Event Type
    Death
    Date Received
    April 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 15, 2025
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    IYN
    PMA / PMN Number
    K132304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EPIQ CVX ULTRASOUND SYSTEM DISPLAYED AN ERROR CODE DURING A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) EXAMINATION ON A STROKE PATIENT. THE ISSUE REMAINED AFTER THE SYSTEM WAS RESTARTED TWICE. THE PROCEDURE WAS ABLE TO BE COMPLETED AFTER AN EXCHANGE OF THE ULTRASOUND SYSTEM. THE PATIENT ULTIMATELY EXPIRED; HOWEVER, THERE IS CURRENTLY NO EVIDENCE TO SUGGEST THE PATIENT EXPIRED AS A RESULT OF THE DEVICE MALFUNCTION AND ADDITIONAL INFORMATION IS BEING OBTAINED. A PHILIPS SERVICE ENGINEER REPLACED THE SYSTEM¿S ACQUISITION MODULE TO ADDRESS THE CUSTOMER¿S IMMEDIATE CONCERN. 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
    2378732 EPIQ CVX SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, INC EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death