Bunnell—Disposable Patient Circuits: Heater Wire Insulation May Melt, Potentially Causing Sparking and Smoke

ECRI Institute’s complete weekly summary of medical device hazard and recall information is available in ECRI Institute’s Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

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,...