GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a display…

Date posted by the FDA

Sept. 24, 2008

Status

Terminated

Filed by

GE Healthcare

Product

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

Distribution pattern

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

Codes and lots

Serial Number CBCL01134 CBCL01133 CBCL01128 CBCL01089 CBCL01087 CBCL01084 CBCL01075 CBCL01072 CBCL01070 CBCL01068 CBCL01067 CBCL01051 CBCL01050 CBCL01022 CBCL01021- CBCL01019 CBCL01018 CBCL01015 CBCL01012 CBCL01011 CBCL01010 CBCL01009 CBCL01008 CBCL01007 CBCL01000 CBCL00998 CBCL00997 CBCL00996 CBCL00995 CBCL00994 CBCL00993 CBCL00985 CBCL00984 CBCL00983 CBCL00978 CBCL00975 CBCL00974 CBCL00973 CBCL00972 CBCL00971 CBCL00968 CBCL00967 CBCL00966 CBCL00965 CBCL00964 CBCL00963 CBCL00962 CBCL00959 CBCL00958 CBCL00957 CBCL00956 CBCL00955 CBCL00954 CBCL00953 CBCL00952 CBCL00951 CBCL00950 CBCL00949 CBCL00948 CBCL00947 CBCL00946 CBCL00945 CBCL00944 CBCL00943 CBCL00942 CBCL00941 CBCL00940 CBCL00939 CBCL00938 CBCL00937 CBCL00936 CBCL00935 CBCL00934 CBCL00933 CBCL00932 CBCL00931 CBCL00930 CBCL00929 CBCL00928 CBCL00927 CBCL00926 CBCL00925 CBCL00924 CBCL00923 CBCL00922 CBCL00916 CBCL00915 CBCL00914 CBCL00913 CBCL00912 CBCL00911 CBCL00910 CBCL00909 CBCL00908 CBCL00907 CBCL00906 CBCL00905 CBCL00904 CBCL00903 CBCL00902 CBCL00901 CBCL00900 CBCL00899 CBCL00898 CBCL00897 CBCL00896 CBCL00895 CBCL00894 CBCL00893 CBCL00892 CBCL00891 CBCL00890 CBCL00889 CBCL00888 CBCL00887 CBCL00886 CBCL00885 CBCL00884 CBCL00883 CBCL00882 CBCL00881 CBCL00880 CBCL00879 CBCL00878 CBCL00877 CBCL00876 CBCL00875 CBCL00874 CBCL00873 CBCL00872 CBCL00871 CBCL00870 CBCL00869 CBCL00868 CBCL00867 CBCL00866 CBCL00865 CBCL00864 CBCL00863 CBCL00862 CBCL00861 CBCL00860 CBCL00859 CBCL00858 CBCL00857 CBCL00856 CBCL00855 CBCL00854 CBCL00853 CBCL00852 CBCL00851 CBCL00850 CBCL00849 CBCL00848 CBCL00847 CBCL00846 CBCL00845 CBCL00844 CBCL00843 CBCL00841 CBCL00840 CBCL00839 CBCL00837 CBCL00836 CBCL00835 CBCL00833 CBCL00832 CBCL00831 CBCL00830 CBCL00829 CBCL00828 CBCL00827 CBCL00826 CBCL00825 CBCL00824 CBCL00823 CBCL00821 CBCL00820 CBCL00818 CBCL00817 CBCL00816 CBCL00815 CBCL00814 CBCL00813 CBCL00812 CBCL00811 CBCL00810 CBCL00809 CBCL00808 CBCL00807 CBCL00806 CBCL00805 CBCL00804 CBCL00803 CBCL00802 CBCL00801 CBCL00800 CBCL00799 CBCL00798 CBCL00797 CBCL00796 CBCL00795 CBCL00794 CBCL00793 CBCL00792 CBCL00791 CBCL00790 CBCL00789 CBCL00788 CBCL00787 CBCL00786 CBCL00785 CBCL00784 CBCL00783 CBCL00782 CBCL00781 CBCL00780 CBCL00779 CBCL00778 CBCL00777 CBCL00776 CBCL00775 CBCL00774 CBCL00773 CBCL00772 CBCL00771 CBCL00770 CBCL00769 CBCL00768 CBCL00767 CBCL00766 CBCL00765 CBCL00764 CBCL00759 CBCL00758 CBCL00757 CBCL00756 CBCL00755 CBCL00754 CBCL00753 CBCL00752 CBCL00751 CBCL00750 CBCL00749 CBCL00748 CBCL00747 CBCL00746 CBCL00745 CBCL00744 CBCL00743 CBCL00742 CBCL00741 CBCL00740 CBCL00739 CBCL00738 CBCL00737 CBCL00736 CBCL00735 CBCL00734 CBCL00733 CBCL00732 CBCL00731 CBCL00730 CBCL00729 CBCL00728 CBCL00727 CBCL00726 CBCL00725 CBCL00724 CBCL00723 CBCL00722 CBCL00721 CBCL00720 CBCL00719 CBCL00718 CBCL00717 CBCL00716 CBCL00715 CBCL00714 CBCL00713 CBCL00712 CBCL00711 CBCL00710 CBCL00709 CBCL00708 CBCL00707 CBCL00706 CBCL00705 CBCL00704 CBCL00703 CBCL00702 CBCL00701 CBCL00700 CBCL00699 CBCL00698 CBCL00697 CBCL00696 CBCL00695…

Recall started

April 23, 2008

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-1829-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1829-2008. The agency record governs; check it and the company before acting.