BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE 3D VIEWER SYSTEM

    MDR report key: 5597092 · Received April 22, 2016

    Report

    Report Number
    3011501361-2016-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2016
    Date of Event
    March 24, 2016
    Report Date
    April 11, 2016
    Manufacturer
    ECHOPIXEL INC
    Product Code
    LLZ
    PMA / PMN Number
    K142107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC MEDICAL DEVICE FAILURE. NO PATIENTS INVOLVED. ISSUE IDENTIFIED DURING ECHOPIXEL INTERNAL TESTING. HEALTH HAZARD EVALUATION COMPLETED BY QUALITY MANAGEMENT.. ALL CURRENT USERS OF PRODUCT HAVE BEEN CONTACTED, PROVIDED INFORMATION ON THE ISSUE. ALL CURRENT USERS HAVE INDICATED THAT NONE USE THE STATED ENHANCED MULTI-FRAME CT FORMATTED DICOM DATA, THEREFORE NO RISK TO PATIENTS CORRECTIVE ACTION PROCESS IN PLACE. NO SPECIFIC DEVICE FAILURE INVOLVED.

    Description of Event or Problem · 1

    PROBLEM: NO PATIENT INVOLVEMENT, PROBLEM IDENTIFIED DURING INTERNAL TESTING. POTENTIAL HAZARD(S): WHEN USING ENHANCED CT FORMAT DICOM DATA, THERE MAY BE: INCORRECT ORIENTATION OF DISPLAYED IMAGE DATA INDICATING INCORRECT PATIENT SIDE (LEFT, RIGHT, SUPERIOR, INFERIOR, ANTERIOR OR POSTERIOR) (SIDEDNESS). INACCURATE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257418 TRUE 3D VIEWER SYSTEM RADIOLOGY IMAGING SYSTEM (LLZ) LLZ ECHOPIXEL INC TRUE 3D VIEWER SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other