BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE 3D VIEWER SOFTWARE

    MDR report key: 7290502 · Received February 22, 2018

    Report

    Report Number
    3011501361-2018-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 19, 2018
    Report Date
    February 21, 2018
    Manufacturer
    ECHOPIXEL, INC.
    Product Code
    LLZ
    UDI-DI
    00851325007003
    PMA / PMN Number
    K170167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NO KNOWN EVENT OCCURRED. PROBLEM: THE IMPORT OF ENHANCED ULTRASOUND FORMATTED DATA (NEMA DICOM SUPPLEMENT 43: STORAGE OF 3D ULTRASOUND DATA, VERSION: FINAL TEXT - (B)(6) 2009), CAN RESULT IN INCORRECT DISPLAY OF IMAGE ORIENTATION. THE REASON WAS AN INCORRECT UNDERSTANDING OF THE DATA FORMAT. THIS FAULT DOES NOT RESIDE IN THE TRUE 3D RENDER ENGINE, BUT RATHER IS LOCALIZED TO THE DICOM INPUT TASK OF THE APPLICATION PROBLEM: THE IMPORT OF PHILIPS 3DDCM FORMATTED ULTRASOUND IMAGES CAN RESULT IN INCORRECT DISPLAY OF IMAGE ORIENTATION. THE REASON WAS AN INCORRECT UNDERSTANDING OF THE DATA FORMAT. THIS FAULT DOES NOT RESIDE IN THE TRUE 3D RENDER ENGINE, BUT RATHER IS LOCALIZED TO THE DICOM INPUT TASK OF THE APPLICATION. ISSUE WAS IDENTIFIED ON RELEASE VERSIONS: 1.6.1 AND 1.6.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132116 TRUE 3D VIEWER SOFTWARE TRUE 3D VIEWER LLZ ECHOPIXEL, INC. EP-00003 N/A 00851325007003

    Patients

    Seq Age Sex Outcome Treatment
    1