Recall Z-1829-2008 · CBK Ventilator, Continuous, Facility Use

GE Healthcare

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 monito

Date	Sep 24, 2008 (initiated Apr 23, 2008)
Status	Terminated
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
Root cause	Device Design
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.
Quantity	1130
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, BELGI
FDA record	Open on fda.gov

510(k) clearances named in this recall

K062710

GE DATEX-OHMEDA ENGSTROM CARESTATION
Datex-Ohmeda, Inc., Dec 8, 2006