BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 7221041 · Received January 26, 2018

    Report

    Report Number
    8031033-2018-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    December 1, 2017
    Report Date
    February 28, 2018
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS NOT AFFECTED BASED ON THE INFORMATION THE (B)(6) HOSPITAL PROVIDED.

    Description of Event or Problem · 1

    EXCERPT OF THE REPORT OF OUR (B)(4) DISTRIBUTOR: INCIDENT DESCRIPTION NARRATIVE / BASED ON THE DISTRIBUTOR ((B)(4)): THE DEVICE PASSES THE SELF TEST WITHOUT ANY PROBLEM. BEGINNING OF THE PROCEDURE PATIENT VENTILATION OK ABOUT TEN MINUTES THEN AN ERROR MESSAGE "NO COMMUNICATION BETWEEN THE UNIT AND THE CENTRAL UNIT" + ALARM SOUND, THE DEVICE NO LONGER VENTILATES AND NO LONGER RESPONDS TO COMMANDS. STOPPING THE PROCEDURE, THE PATIENT MUST BE REINTEGRATED WITH A TRADITIONAL INTUBATION PROBE AND VENTILATED OTHERWISE. ATTEMPTING TO REBOOT THE DEVICE : (B)(6) MESSAGE DISPLAYED, WITHOUT VENTILATION, AND THE DEVICES STOPS. AFTER A NEW REBOOT, (B)(6) LANGUAGE DISPLAY AND VENTILATE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65092 MONSOON III MONSOON III CBK ACUTRONIC MEDICAL SYSTEMS AG 212101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown