BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18796472 · Received February 28, 2024

    Report

    Report Number
    3004455125-2024-00003
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    April 2, 2022
    Report Date
    February 26, 2024
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    PMA / PMN Number
    K173381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ALL SCREENS WENT BLACK ONE BY ONE. ORDER WAS VARSIMONITORI 4, VARSIMONITORI 3, VARSIMONITORI 2, VARSIMONITORI 1. THE SCREENS WERE NOT WORKING FOR ABOUT 15 SECONDS. "NO SIGNAL" WAS DISPLAYED. *SAME SOURCE (ENDOSCOPE) WAS ROUTED T*O ALL SCREENS SO ISSUE CAN NOT BE SOURCE RELATED VARSIMONITORI 4 WAS BEING RECORDED THE WHOLE OPERATION. IN THE CONTROL SCREEN THE THUMBNAILS WERE SHOWING THE SOURCE IN THE SCREEN THAT WAS BLACK. FAILOVER: NO DELAY HAPPENED DUE TO THE ENDOSCOPE BEING CONNECTED TO A BACKUP SCREEN. ARE YOU ABLE TO REPRODUCE WHAT ARE THE CIRCUMSTANCES: NO EXACT CIRCUMSTANCES, THE ISSUE HAPPENS RANDOMLY. ONCE THE SCREENS GO BLACK, THEY GO BACK TO NORMAL OPERATION AFTER A COUPLE OF SECONDS. IT IS POSSIBLE THAT THIS ISSUE WAS CAUSED BY A MALFUNCTION OF NEXXISOR NO HEALTH CONSEQUENCES OR IMPACT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451307 BARCO NEXXISOR DXJ BARCO NV NEXXIS OR 1.18.01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown