BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON

    MDR report key: 11098574 · Received December 30, 2020

    Report

    Report Number
    8031033-2020-00011
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Report Date
    December 2, 2020
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. VYAIRE MEDICAL DETERMINED ROOT CAUSE AS DUE TO USER FAULT, WRONG HANDLING BY CUSTOMER/USER - A HOSE "FLEW OFF" DUE TO THE USAGE OF A SYRINGE AND OF AN IV SYSTEM WITH A NON-RETURN VALVE. ADVISED CUSTOMER THAT THE USAGE OF A SYRINGE AND AN IV SYSTEM WITH A NON-RETURN VALVE FOR THE FUTURE WILL BE PROHIBITED.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE CUSTOMER REPORTED MONSOON 4 WENT OUT DURING OPERATION AND RESTARTED BY ITSELF. THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563241 MONSOON VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON 4 DOUBLE +

    Patients

    Seq Age Sex Outcome Treatment
    1