BEUDAMED
    FDA Enforcement Class II Completed

    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

    Recall: Z-1966-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1966-2023
    Event ID
    92243
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Vyaire Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2023
    Initiation Date
    May 5, 2023
    Classification Date
    June 14, 2023
    Address
    26125 N Riverwoods Blvd, N/A, Mettawa, IL, 60045-3420, United States

    Description

    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator

    Reason

    Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang). When this occurs, if the user continues to interact with the touchscreen, a message will appear that states DeviceSoftware.Application is not responding or a decommission screen will appear on the user interface. The ventilator will issue both an audible and visual alarm. Ventilation continues without interruption with the settings applied prior to the APP Hang error. 2. The potential for a use error has been identified if the operator applies the proposed settings without confirming the settings are suitable for the patient.

    Code Info

    UDI/DI: 10190752197664 and 07640149381115, ALL serial numbers with Software Version 6.1.0.2 and 6.1.1

    Distribution

    US Nationwide Distribution

    Quantity

    910 units