BEUDAMED
    FDA Enforcement Class I Terminated

    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    Recall: Z-1892-2016 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1892-2016
    Event ID
    74111
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 211 Inc dba Carefusion
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    May 17, 2016
    Classification Date
    June 13, 2016
    Termination Date
    September 28, 2017
    Address
    22745 Savi Ranch Pkwy, Yorba Linda, CA, 92887-4668, United States

    Description

    AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    Reason

    CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).

    Distribution

    Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

    Quantity

    922 units total (501 units in US)