BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 11771897 · Received May 4, 2021

    Report

    Report Number
    3004553423-2021-01015
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 7, 2021
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE IDENTIFICATION NUMBER: (B)(4). IT WAS SUSPECTED BY THE TECHNICIAN THAT THE PROBLEM WAS LIKELY DUE TO THE PROPORTION VALVE ON THE OXYGEN SIDE. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONSOON III BASIC IS NOT REACHING THE SET OXYGEN CONCENTRATION. PATIENT INVOLVEMENT IS UNKNOWN AS OF THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665012 MONSOON III VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON III

    Patients

    Seq Age Sex Outcome Treatment
    1