BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18796477 · Received February 28, 2024

    Report

    Report Number
    3004455125-2024-00010
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    November 2, 2022
    Report Date
    February 14, 2024
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    PMA / PMN Number
    K173381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    REPORTED FAILURE: AFTER THE INTRODUCTION OF THE NIS FOR THE INTEROR SETUP, THE BLACK SCREEN ISSUE STABILIZED FOR MOST ROOMS, EXCEPT FOR 2 ROOMS. + ISSUE DETERMINATION DIFFICULT: OCCURRENCE 1X PER MONTH. + NTP SERVER INTRODUCED FOR BETTER TIMING DETERMINATION. + LOGFILES PROVIDED BY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451312 BARCO NEXXISOR, MNA-440 ENC SDI DXJ BARCO NV NEXXISOR, MNA-440 ENC SDI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown