BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 16410209 · Received February 21, 2023

    Report

    Report Number
    8031033-2023-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 21, 2023
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED TO VYAIRE MEDICAL FOR EVALUATION. HOWEVER, THE ROOT CAUSE COULD NOT BE ASCERTAINED. AN EVENT TRACE WAS PERFORMED, AND THE LOGS CONFIRMED THAT THE CUSTOMER¿S REPORTED ISSUE DID TRANSPIRE. AS A PRECAUTIONARY MEASURE, THE UNIT WAS TAKEN OUT OF CIRCULATION AND REPLACED WITH ANOTHER UNIT. ISSUE IS NO LONGER REPRODUCIBLE.

    Additional Manufacturer Narrative · 0

    OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MONSOON III VENTILATOR ALARMED "PEAK INSPIRATORY PRESSURE WAS TOO HIGH" DURING PATIENT USE.WHEN END USER TRIED TO ACKNOWLEDGE/MUTE THE ALARM, THE DISPLAY COMPLETELY FROZE. THE UNIT COULD NO LONGER BE OPERATED, BUT IT CONTINUED TO VENTILATE. END USER SWITCHED IT OFF BY PULLING THE MAINS PLUG. AFTER RESTARTING, THE UNIT IMMEDIATELY CONTINUED VENTILATION AND COULD THEN BE OPERATED NORMALLY. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385773 MONSOON III VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON III

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown