BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONSOON+

    MDR report key: 8805622 · Received July 18, 2019

    Report

    Report Number
    8031033-2019-00001
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 18, 2019
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    UDI-DI
    07640140861616
    PMA / PMN Number
    K012691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: ACUTRONIC SUPPORT IN CONJUNCTION WITH THE CUSTOMER DETERMINED THE MOST LIKELY CAUSE OF THE EVENT IS THE MOTHERBOARD. ADDITIONAL INFORMATION WAS REQUESTED ON WHETHER OR NOT THE REPAIRS WILL BE DONE BY DISTRIBUTOR OR ACUTRONIC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONSOON VENTILATOR ALARMED WITH THE FOLLOWING ISSUES: PEAK INSPIRATORY PRESSURE (PIP) MEASURING ELECTRONIC ERROR AND DRIVING (DP) MEASURING ELECTRONIC ERRORS. THE ISSUE OCCURRED DURING PATIENT USE IN ADULT DOUBLE JET VENTILATION MODE. THE CUSTOMER REPORTED THE ERROR OCCURRED TWICE DURING A TWELVE HOUR SHIFT AND WAS STILL IN USE. AT THIS TIME, THERE IS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596869 MONSOON+ VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG 7700.US 07640140861616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other