There is a potentially defective component on the Trilogy Ventilator power management board which could affect the function of the device. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm388421.htm |