BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARCO

    MDR report key: 17411915 · Received July 28, 2023

    Report

    Report Number
    3004578804-2022-00001
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    January 21, 2022
    Report Date
    February 18, 2022
    Manufacturer
    BARCO NV
    Product Code
    DXJ
    Removal / Correction Number
    Z-1854-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATIONS PERFORMED: 1/ INSPECTION OF LOCAL INSTALLATION IN SWITZERLAND; 2/ INTERVIEWS OF INVOLVED MEDICAL STAFF AND SURGEONS IN SWIZERLAND & INTERVIEWS WITH BOARD OF SURGEONS; 3/ ANALYSIS OF INVOLVED MNA-240 ENC DEVICES (INVESTIGATION OF AIR FLOW AND THERMAL DYNAMICS), REPRODUCTION OF ISSUE BY R&D; 4/ STUDY OF EXISTING INFO-T & INSTALLATION MANUAL, SUFFICIENT INFORMATION TO SAFEGUARD CORRECT INSTALLATION BY END USERS? CONCLUSION FROM INVESTIGATIONS / ROOT CAUSE INVESTIGATION: - TEMPERATURE INSIDE DEVICE EXCEEDS THE TEMPERATURE LIMIT; - MNA DEVICES FAIL AND HAVE NO VIDEO OUTPUT; - INTERNAL LDO COMPONENT GOES IN THERMAL SHUTDOWN; - INSTALLATION OF THE DEVICES WAS NOT ACCORDING THE INSTRUCTIONS; - INSTRUCTIONS NOT SUFFICIENTLY ACCURATE. ACTION IN THE FIELD: - UPDATE INSTALLATION INSTRUCTIONS; - INFORM CUSTOMERS TO INSPECT CURRENT INSTALLATIONS AND ADHERE TO THE UPDATED INSTRUCTIONS.

    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 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

    DURING A PROCEDURE ALL MONITORS HAVE SHUT DOWN. DEVICES NOT RESPONDING. THE PATIENT HAD TO BE TRANSPORTED TO ANOTHER OPERATING ROOM WITH LAPAROSCOPIC INSTRUMENTS IN HER ABDOMEN AND INTUBATED. ANOTHER OPERATING ROOM HAD TO BE FREE FIRST. LONGER ANESTHESIA TIME FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968329 BARCO MNA-240 DXJ BARCO NV MNA-240

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention