Bunnell—Disposable Patient Circuits: Heater Wire Insulation May Melt, Potentially Causing Sparking and Smoke
December 12, 2012 | Strategic Insights for Health System
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In a November 19, 2012, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, Bunnell states that it has received 11 reports of the heater wire insulation of the circuits below melting near the humidifier cartridge, causing sparking and smoke. Bunnell also states that it has received no reports of patient injury or death associated with this problem; however, the potential exists for the following adverse events to occur:
FDA issued a December 5, 2012,...