BEUDAMED
    FDA Enforcement Class II Terminated

    Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

    Recall: Z-2094-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2094-2015
    Event ID
    69760
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Breas Medical AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 22, 2015
    Initiation Date
    November 7, 2014
    Classification Date
    July 16, 2015
    Termination Date
    April 7, 2016
    Address
    Foretagsvagen 1, N/A, Molnlycke, N/A, N/A, Sweden

    Description

    Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

    Reason

    Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.

    Code Info

    All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04

    Distribution

    Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.

    Quantity

    846 US