BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMTMEDICAL / VYAIRE MEDICAL

    MDR report key: 13541885 · Received February 15, 2022

    Report

    Report Number
    MW5107462
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    February 10, 2022
    Report Date
    February 11, 2022
    Manufacturer
    IMTMEDICAL / VYAIRE MEDICAL, INC.
    Product Code
    CBK
    UDI-DI
    07640149381115
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A VYAIRE, BELLAVISTA 1000 VENTILATOR, S/N: (B)(4), UDI: (B)(4), STOPPED WORKING AND SHUT DOWN WHILE BEING USED TO VENTILATE A PATIENT. THE ERROR OCCURRED WHEN A CLINICIAN ATTEMPTED TO CHANGE VENTILATION MODES; UPON CHANGING THE MODES AND HITTING THE 'APPLY MODE' BUTTON, THE VENTILATOR SHUT DOWN AND ALARMED, STATING ON-SCREEN TO REMOVE FROM SERVICE AND CONTACT TECHNICAL SUPPORT. THIS ISSUE WAS IMMEDIATELY REPORTED TO THE MANUFACTURER, VYAIRE MEDICAL, AND AN OFFICIAL COMPLAINT WAS REQUESTED TO BE FILED REGARDING THIS INCIDENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3280 IMTMEDICAL / VYAIRE MEDICAL VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL / VYAIRE MEDICAL, INC. BELLAVISTA 1000 2019-07-29 07640149381115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L