BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIQ CVX ULTRASOUND SYSTEM

    MDR report key: 18703752 · Received February 14, 2024

    Report

    Report Number
    18703752
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 2, 2024
    Manufacturer
    PHILIPS ULTRASOUND, LLC.
    Product Code
    IYN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE SCANNING A PATIENT IN OUR CONTRAST SETTING, I UTILIZED A "FLASH" BUTTON TO REDISTRIBUTE THE CONTRAST AND UPON HITTING THE FLASH BUTTON THE PATIENT AWOKE AND YELPED. WHEN I ASKED IF HE WAS OK AND WHAT HAPPENED HE SAID HE WAS FINE BUT FELT LIKE HE RECEIVED A STATIC SHOCK. HE SAID THERE WAS NO RESIDUAL PAIN, AND HE FELL BACK ASLEEP. THERE WAS NO REDNESS OR MARKS LEFT ON THE PATIENT, AND PATIENT STATED HE FELT FINE WHEN ECHO COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242991 EPIQ CVX ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC IYN PHILIPS ULTRASOUND, LLC. 795231

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown