BEUDAMED
    FDA Recall Terminated

    GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.

    Recall: Z-1829-2008 · Initiated April 23, 2008

    Recall

    Recall Number
    Z-1829-2008
    Event Number
    48080
    Firm
    GE Healthcare
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 23, 2008
    Posted
    September 24, 2008
    Terminated
    May 16, 2012
    Address
    9900 Innovation Drive, Wauwatosa, WI, 53226

    Description

    GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator.

    Reason

    There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while the nebulizer is active, may result in the discontinuance of mechanical ventilation. This issue affects all of the Engstrm Carestations shipped between 12/4/2006

    Action

    Consignees were sent a "GE Urgent Medical Device Correction" letter on 5/12/08 addressed to Health Care Administrator/Risk Manger, Chief of Intensive Care & Director of Clinical Engineering. The letter described the affected product and the problem and provided a short term recommendation and a long term solution which included installation of a revised board on all affected Engstrom Carestations. A GE Healthcare Field Service Engineer to contact the facility to schedule the update. If you have questions, contact Melissa Davis at GE Healthcare at 1-800-345-2700 extension 3439.

    Distribution

    WI, GA, SC, TX, RI, NY, NM, IN VIETNAM, VENEZULA, UNITED KINGDOM, TURKEY, KOREA, JAPAN, ITALY, INDIA, ICELAND, HONG KONG, GREECE, GERMANY, GEORGIA, FRANCE, TUNISIA, THAILAND, SWITZERLAND, SPAIN, SOUTH AFRICA, FINLAND, ESTONIA, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CANADA, BRAZIL, BELGIUM, BANGLADESH, BAHRAIN, SLOVENIA, SINGAPORE, SAUDI, RUSSIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, NETHERLAND,MOROCCO, MEXICO, MAYLASIA, LYBIA, LEBANON, KUWAIT, AUSTRIA, AUSTRALIA.

    Quantity

    1130