BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO INC

    MDR report key: 13019780 · Received December 16, 2021

    Report

    Report Number
    3004578804-2021-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 15, 2021
    Manufacturer
    BARCO INC
    Product Code
    FWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THE COMPLAINT FORM FROM OUR CUSTOMER DID NOT CONTAIN SUFFICIENT INFORMATION FOR BARCO TO DETERMINE THE TECHNICAL AND CLINICAL CIRCUMSTANCES THAT HAVE LED TO THIS EVENT. WE WERE NOT ABLE TO DETERMINE THE ROOT CAUSE. WE HAVE ATTEMPTED 3 TIMES TO RECEIVE MORE INFORMATION THAT WOULD ALLOW TO DETERMINE THE TECHNICAL AND CLINICAL CAUSES BUT WE RECEIVED NO FEEDBACK.

    Description of Event or Problem · 0

    "CUSTOMER REPORTED THAT DURING A PROCEDURE "THE IMAGE ON THE SCREEN WASN'T SUITABLE." THE SURGEON "REPORTED THAT THE BLOOD ON THE VIDEO WAS ACTUALLY BILE WHICH IS GREEN." "THIS COLOUR OF THE FLUID LOOKED BLOOD LIKE" BUT SURGEON "SAID WHEN IT CAME OUT OF THE SUCTION IT WAS GREEN." THE SURGEON STOPPED LAPAROSCOPIC APPROACH AND MOVED TO AN OPEN PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913990 BARCO INC 4K DISPLAY INTERNATIONAL KIT FWB BARCO INC 0240-031-050

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Unknown Required Intervention