BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 11399691 · Received March 2, 2021

    Report

    Report Number
    3004553423-2021-00864
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 2, 2021
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. VYAIRE MEDICAL DETERMINED ROOT CAUSE AS REPRODUCIBLE BUT NOT A FAILURE BUT AN OPERATION OF A COMMAND OR A MISINTERPRETATION BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    VYAIRE TECHNICAL SUPPORT RECEIVED THE LOG FILES SENT BY THE CUSTOMER. LOG FILE ANALYSIS REVEALS "PIP_TO_HIGH," A STANDARD PATIENT ALARM IN WHICH SET LIMIT HAS BEEN EXCEEDED. HOWEVER, THIS CAN BE DUE TO HANDLING ERROR AS THE PIP (PEAK INSPIRATORY PRESSURE) CHANNEL HAS ITS OWN FLOW IN ORDER TO AVOID THAT A BLOCKAGE OF THE CHANNEL GOES UNNOTICED. ALSO, ACCIDENTAL CHANGES ARE PREVENTED BY A DOUBLE CONFIRMATION (OPERATE TOUCHSCREEN, THEN TURN THE ROTARY KNOB, CONFIRM BY PRESSING). THE CUSTOMER HAS BEEN REQUESTED FOR MORE INFORMATION (WHEN IT OCCURRED, WHO DISCOVERED IT, WHAT APPLICATION WAS USED, HOW LONG IS THE OPERATION TIME, WHAT APPLICATORS WERE USED) AND PHOTOS OF FAILURE. THE SUSPECT DEVICE IS IN TRANSIT TO MANUFACTURER FOR EVALUATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SETTINGS CHANGED BY THEMSELVES, WITHOUT TOUCHING THE MONSOON III BASIC. IT HAPPENED DURING PATIENT VENTILATION. HOWEVER, THERE IS NO INFORMATION REGARDING OUTCOME OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297306 MONSOON III VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON III

    Patients

    Seq Age Sex Outcome Treatment
    1