The FDA notified health care professionals and their provider organizations of the Class I Recall of the Bunnell life pulse high-frequency ventilator patient circuits that have been found to have heater wire insulation that can melt, causing sparking and smoke close to the humidifier cartridge. This can cause serious adverse consequences, including death.
Patient circuits are used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The patient circuit provides a conduit for humidifying, warming, and temperature monitoring of the pressurized gas.
Visit Bunnell’s Web site for more information on the affected devices.
Read the FDA notice by clicking here.