BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 8004123 · Received October 25, 2018

    Report

    Report Number
    9613188-2018-00001
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    September 26, 2018
    Report Date
    October 24, 2018
    Manufacturer
    BARCO NV
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING MINIMALLY-INVASIVE SURGERY THE SURGICAL DISPLAY SWITCHED TO STANDBY AND COULD NOT BE REACTIVATED IMMEDIATELY. BECAUSE THE BACKUP SCREEN WAS NOT AVAILABLE (THE SCREEN WAS POSITIONED BEHIND THE SURGEON) THE SURGEON DECIDED TO SWITCH FROM LAPAROSCOPY TO OPEN SURGERY. THERE WAS NO MALFUNCTION IN THE DISPLAY. THE PATIENT RECOVERED WELL AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843983 BARCO MDSC-8255 MNA KQM BARCO NV MDSC-8255 MNA

    Patients

    Seq Age Sex Outcome Treatment
    1