BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 20107071 · Received August 30, 2024

    Report

    Report Number
    3004455125-2024-00018
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 30, 2024
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    PMA / PMN Number
    K173381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE IS THE BROADCAST ENABLE THAT WAS NOT SET.

    Additional Manufacturer Narrative · 0

    ON 21-JAN-2022, THERE WAS AN EVENT WITH BARCO'S MNA-240 DEVICE IN A HOSPITAL IN SWITZERLAND, WHEREBY THE PATIENT EXPERIENCED HARM BECAUSE OF BEING TRANSPORTED TO ANOTHER OPERATING ROOM. BARCO HAS REPORTED THIS EVENT IN REPORT NO. 3004578804-2022-00001 (MDR REPORT KEY (B)(4). SINCE THEN, IN LINE WITH THE GUIDANCE DOCUMENT 'MEDICAL DEVICE REPORTING FOR MANUFACTURERS' FROM NOVEMBER 2016, BARCO HAS CONSIDERED THE LIKELIHOOD OF HARM FROM SIMILAR INCIDENTS WITH SIMILAR DEVICES TO BE 'LIKELY' REGARDLESS OF IF THE INCIDENT ACTUALLY LED TO HARM OR NOT. HOWEVER, SINCE THE INCIDENT FROM 2022 BARCO HAS NOT RECEIVED ANY SIMILAR COMPLAINTS WITH ACTUAL HARM ANYMORE. THEREFORE, ALSO CONFORM THE SAME GUIDANCE DOCUMENT, BARCO NO LONGER CONSIDERS SIMILAR INCIDENTS TO BE LIKELY TO LEAD TO DEATH OR SERIOUS HARM. ANY RECURRENCE OF A SERIOUS INJURY OR DEATH FOR THE SAME MALFUNCTION IN THE FUTURE WILL TRIGGER THE RESUMPTION OF MANDATORY REPORTING AGAIN.

    Description of Event or Problem · 0

    IN SEVERAL OPERATING ROOMS THE DISPLAYS DISAPPEARED FROM THE MANAGEMENT SOFTWARE CONSOLE AND IN SOME CASES THE IMAGE ON THE DISPLAY DROPPED. THIS HAPPENED OVER A PERIOD OF SEVERAL DAYS. THE PROBLEMS WERE SOLVED BUT REAPPEARED A FEW DAYS LATER. AFTER 2 FACTORY RESETS THE ROOM WORKS FINE AGAIN WITHOUT LOSING THE DISPLAYS. IN SOME CASES THIS HAPPENED DURING SURGERY ACCORDING TO THE COMPLAINT. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911277 BARCO NEXXISOR DXJ BARCO NV NEXXISOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown