AUDIENCE: Risk Manager, Biomedical Engineering
ISSUE: FDA notified healthcare professionals and medical care organizations of the Class 1 recall of certain models of Respironics' Trilogy ventilators due to defective power supply components that may cause unexpected cessation of function, thereby stopping ventilation of the patient. There may also be failure of the ventilator alarm to sound. Affected Model/Catalog Numbers are 1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.
BACKGROUND: The Trilogy 100, 200, and 202 ventilators are intended for continuous or intermittent breathing support for patient populations ranging from pediatric patients, weighing at least 11 pounds, to adult patients. The ventilators are used in hospitals, nursing homes, other health care settings, and in the home. These ventilators were manufactured from January 1, 2012 through April 27, 2012 and distributed from March 1, 2012 through May 1, 2012.
RECOMMENDATION: The recall was initiated April 27, 2012 and Respironics, Inc. began contacting their affected U.S. customers by phone. The firm requested customers to quarantine any affected devices within their possession and to retrieve any devices with patients and quarantine those as well. The company will provide replacement devices to all affected customers. In the time period prior to Respironics replacing the device, the patient’s health care providers should provide an alternative device. Affected customers may contact Respironics Customer Service at 1-877-387-3311.
[08/02/2012 - Recall Notice - FDA]