BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONSOON+

    MDR report key: 8903212 · Received August 16, 2019

    Report

    Report Number
    8031033-2019-00004
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    April 12, 2019
    Report Date
    April 12, 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
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED FOR ANALYSIS AND INVESTIGATION. THE CAUSE OF THE ISSUE WAS ATTRIBUTED TO A DEFECTIVE MMI. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE STOPPED VENTILATING DURING CLINICAL USE. ADDITIONALLY, AN ERROR MESSAGE "ELECTRONIC ERROR" OCCURRED DURING THE INITIATION OF THE PATIENT TO MICROLARYNGOSCOPY. ALL BUTTONS WERE INOPERATIVE AND DISPLAY IS NOT FUNCTIONING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697203 MONSOON+ VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG 7700.US 07640140861616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other