BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III BASIC

    MDR report key: 9708156 · Received February 13, 2020

    Report

    Report Number
    8030673-2020-00073
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 12, 2020
    Report Date
    January 13, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINE YET. THE REPORTED ISSUE OCCURRED WITH SERIAL NUMBERS (B)(4). THIS REPORT IS FOR SERIAL NUMBER (B)(4); PLEASE REFER TO (B)(4) FOR THE INCIDENT INVOLVING LOT NUMBER (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY OF THE MONSOON III BASIC VENTILATOR REMAINS DARK EVEN AFTER REPAIR. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171417 MONSOON III BASIC VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON 3 HFJV BASIC UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1