BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 18796484 · Received February 28, 2024

    Report

    Report Number
    3004455125-2024-00007
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 22, 2022
    Report Date
    February 14, 2024
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    PMA / PMN Number
    K173381
    Removal / Correction Number
    RECALL NUMBER Z-1854-202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDICAL SPECIALIST HAS CONFIRMED THAT THE EXTENSION OF ANESTHESIA, AS REPORTED BY THE CUSTOMER, DID NOT POSE AN ADDITIONAL RISK TO THE PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER HAS INFORMED BARCO THAT THEY RECEIVED THE FOLLOWING INFORMATION FROM THE HOSPITAL: ALL MONITORS ARE BLACK WHEN BOOTING UP IN THE MORNING. SYSTEM UP AND DOWN SEVERAL TIMES. TIME DELAY APPROX. 20 MINUTES UNTIL THE DECODER ON THE EQUIPMENT TROLLEY WORKED AND SENT A SIGNAL. EVERYTHING WAS STABLE FOR THE REST OF THE DAY. THE NEXT MORNING THERE WERE NO PROBLEMS AT STARTING. IT WAS A USER ERROR THAT THE EMERGENCY LINE WAS ON THE WRONG VIDEO INPUT /4K INSTEAD OF 1080P. IT IS NOT CLEAR WHO SET THIS. THE PATIENT RECEIVED EXTENDED ANESTHESIA. THE SURGERY COULD NOT BE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451319 BARCO NEXXISOR, MNA-240 DXJ BARCO NV MNA-240 ENC DP KS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown