BEUDAMED
    FDA Recall Terminated

    Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

    Recall: Z-2094-2015 · Initiated November 7, 2014

    Recall

    Recall Number
    Z-2094-2015
    Event Number
    69760
    Firm
    Breas Medical AB Foretagsvagen 1 Molnlycke Sweden
    FEI Number
    3003244771
    Product Code
    NOU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 7, 2014
    Posted
    July 16, 2015
    Terminated
    April 7, 2016

    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.

    Action

    Breas Medical sent Urgent Release: Field Safety Notice letters dated November 7, 2014 and Field Safety Notice dated November 21, 2014 to their customers. The letters identified the affected product, problem and the actions to be taken.

    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