BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSOON III

    MDR report key: 10135954 · Received June 9, 2020

    Report

    Report Number
    8031033-2020-00010
    Event Type
    Malfunction
    Date Received
    June 9, 2020
    Date of Event
    April 27, 2020
    Report Date
    May 11, 2020
    Manufacturer
    ACUTRONIC MEDICAL SYSTEMS AG
    Product Code
    CBK
    PMA / PMN Number
    K012691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: G4, H2, H3, H6 AND H10. RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION AND VYAIRE MEDICAL DETERMINED ROOT CAUSE DUE TO DEFECTIVE ELECTRICAL COMPONENT, 211301.01 MMI COMPLETE. THE DEVICE WAS BEYOND REPAIR AND THE CUSTOMER BOUGHT A NEW ONE.

    Additional Manufacturer Narrative · 1

    VYAIRE FILE IDENTIFICATION: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. HOWEVER, PHOTOGRAPH HAS BEEN SENT FOR EVALUATION AND WILL BE REVIEWED BY TECHNICAL SUPPORT. 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 THAT THE MONSOON III UNIT HAS WIDE BLACK STRIPE ACROSS THE DISPLAY. THE STRIPE STARTS TO APPEAR ON DEVICE START UP THEN STAYS THERE, MAKING THE DISPLAY HARD TO READ. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597677 MONSOON III VENTILATOR, CONTINUOUS, FACILITY USE CBK ACUTRONIC MEDICAL SYSTEMS AG MONSOON 3+ HFJV UNIVERSAL UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1