BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX

    MDR report key: 21355003 · Received February 11, 2025

    Report

    Report Number
    MW5165914
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 2, 2025
    Report Date
    February 4, 2025
    Manufacturer
    PHILIPS ULTRASOUND LLC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHILIPS TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) PROBE USED FOR TRANS ESOPHAGEAL EXAMS CAUSED ULTRASOUND MACHINE TO SHUT DOWN OR NO ECHO IMAGE WHILE IMAGING PATIENTS. MULTIPLE OCCASIONS. MULTIPLE ERROR TYPES ON ULTRASOUND BUT PROBE PASSED ALL ELECTRICAL AND LEAK TESTING PRIOR TO USE. THIS CAUSES THE ULTRASOUND TO REBOOT WHILE PROBE IS IN PATIENT RESULTING IN LONGER TESTS AND DELAYED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042758 EPIQ CVX SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male