BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18796471 · Received February 28, 2024

    Report

    Report Number
    3004455125-2024-00009
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    April 6, 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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BARCO HAS CONCLUDED THAT THE LOSS OF VIDEO SIGNAL IS CAUSED BY A PROBLEM WITH THE SFP MODULES, WHICH IS RELATED TO MAINTENANCE. AFTER REPLACEMENT OF THE SFP MODULES THE PROBLEM WAS SOLVED. WE HAVE NO FEEDBACK SINCE THEN DESPITE SEVERAL ATTEMPTS.

    Description of Event or Problem · 0

    THE CUSTOMER HAS INFORMED BARCO THAT THEY RECEIVED THE FOLLOWING INFORMATION FROM THE HOSPITAL: IMAGE LOSS INTRAOPERATIVELY. THERE WILL NOW BE A SWISSMEDIC MESSAGE FROM THE CUSTOMER. INTRAOPERATIVE IMAGE FAILURE OF THE TWO MONITORS (DEC DP4K) IN THE STERILE FIELD AND THE 55" BARCO WITH BUILT-IN DEC ON THE WALL. ONLY THE SECURELINE WOULD HAVE WORKED (12G-SDI) BUT WAS SWITCHED INCORRECTLY. NOW THE CUSTOMER HAS AGAIN RECEIVED THE SETTING FOR SWITCHING THE SECURELINE VIA VIDEO. I PLAYED IT THROUGH WITH HIM VIA VIDEO SUPPORT. IT WORKS PERFECTLY. AS FAR AS I KNOW, NO PATIENT WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451306 BARCO NEXXISOR DXJ BARCO NV MNA-140 PCIE KS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown