BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 22519606 · Received July 16, 2025

    Report

    Report Number
    3004455125-2025-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 16, 2025
    Manufacturer
    BARCO NV
    Product Code
    KQM
    UDI-DI
    05415334042674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED DURING THE WEEKEND, WHEN NOBODY WAS PRESENT. AFTER THE WEEKEND, THE USER ENTERED THE ROOM AND NOTICED THAT THE FRONT FILTER HAD DETACHED FROM THE DISPLAY AND WAS BROKEN ON THE FLOOR. THE EVENT DID NOT HAPPEN IN THE OPERATING ROOM BUT IN THE CUSTOMER'S EXPERIENCE CENTER. ONE WEEK EARLIER THE CUSTOMER HAD NOTICED THAT THE FRONT FILTER OF THE SAME DISPLAY HAD PARTIALLY COME LOOSE WITHOUT DETACHING COMPLETELY. INSTEAD OF TAKING THE DISPLAY OUT OF SERVICE (AS IS PRESCRIBED IN THE INSTRUCTIONS FOR USE) THE CUSTOMER PUSHED BACK THE FRONT FILTER AND CONTINUED TO USE THE DISPLAY. IT IS THE VERY FIRST TIME THAT WE RECEIVE A COMPLAINT OF A COMPLETELY DETACHED FRONT FILTER. WE HAVE DONE EXTENSIVE TESTING IN OUR LAB TO REPRODUCE THIS FAULT BUT COULD NOT REPRODUCE IT. WE CONCLUDE THAT THE EVENT IS SOLELY CAUSED BY THE MANIPULATION OF THE USER.

    Description of Event or Problem · 0

    ON JUNE 23, WE RECEIVED A COMPLAINT FROM A CUSTOMER ABOUT A FRONT FILTER DETACHMENT. AFTER THE WEEKEND, THE CUSTOMER ENTERED THEIR DEMO ROOM AND NOTICED THAT THE FRONT FILTER (GLASS) HAD COMPLETELY DETACHED FROM THE DISPLAY, FALLEN DOWN AND SHATTERED INTO PIECES. THERE WAS NOBODY NEAR THE DISPLAY AT THE TIME THE GLASS HAD FALLEN. NOBODY HAS SEEN THE GLASS FALLING DOWN. NO INJURIES HAVE BEEN REPORTED. ONE WEEK EARLIER, THE SAME CUSTOMER HAD INFORMED US THAT THE FRONT GLASS OF THE SAME DISPLAY IN THE DEMO ROOM HAD PARTLY DETACHED. IT WAS STILL PARTIALLY ATTACHED TO THE DISPLAY AND WAS NOT COMPLETELY LOOSE. INSTEAD OF TAKING THE DISPLAY OUT OF SERVICE, AS INSTRUCTED IN THE INSTRUCTIONS FOR USE, THE USER PUSHED BACK THE FRONT GLASS. THE EVENT OF PARTIAL DETACHMENT HAS NO RISK AT ALL THAT IT COULD CAUSE OR CONTRIBUTE TO ANY HARM WHATSOEVER, IF IT WOULD OCCUR AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601555 BARCO SURGICAL DISPLAY KQM BARCO NV MDSC-8532 SSTF 05415334042674

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown