The Puritan Bennett 840 Series Ventilator is a critical care ventilator that provides continuous ventilation for infant, pediatric, and adult patients. Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used on critically ill patients who may not be able to continue breathing without the ventilator. This product may cause serious adverse health consequences, including death. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm381044.htm |