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Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient
AUDIENCE: Risk Manager, Nursing, Critical Care Medicine ISSUE: FDA notified healthcare professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm. Failure to respond could result in the potential for harm or death of a ventilator-dependent patient. See the Recall Notice for a list of affected serial numbers. BACKGROUND: The Respironics Trilogy 100 ventilator is intended for continuous or intermittent breathing support for the care of pediatric patients, weighing at least 11 pounds, through adult patients who require mechanical ventilation. The ventilators are used in hospitals, nursing homes and other health care settings, and in the home. RECOMMENDATION: Respironics notified its United States distributors, providers, sales personnel and customers of the recall by telephone on October 11, 2011. The company will continue to work with affected customers to arrange for the return or repair of all recalled ventilators. Read the Medwatch safety alert, including a link to the Recall Notice, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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