BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON+

    MDR report key: 8903785 · Received August 16, 2019

    Report

    Report Number
    8031033-2019-00003
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    UDI-DI
    07640140861616
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE ACUTRONICS SUPPORT TEAM INFORMED THE CUSTOMER THAT THE MMI (MAN MACHINE INTERFACE) WILL BE REPLACED. THE CUSTOMER IS ADVISED TO UPDATE SOFTWARE TO V2.071 SINCE THE NEW COMPONENT HAS A NEW HARDWARE AND SOFTWARE VERSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE EXPERIENCED DISPLAY ISSUES. AT THIS TIME, THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT INVOLVEMENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696069 MONSOON+ VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG 7700.US 07640140861616

    Patients

    Seq Age Sex Outcome Treatment
    1