FDA Issues Recall Of Defective Infant Ventilators

by | January 2nd, 2013

January 2, 2013

The U.S. Food and Drug Administration, along with medical device manufacturer, Bunnell, issued a voluntary recall on the Bunnell Life Pulse High-Frequency Ventilator Patient Circuits due to a manufacturing defect. According to an FDA press release, reports have been made of the device overheating and developing electrical fires.

The Bunnell Life Pulse High-Frequency Ventilator Patient Circuit is used for getting oxygen to sick infants who are not properly responding to conventional ventilation methods. The device works by humidifying and regulating the temperature of gases that are being administered to patients through the device.

The recall was issued after the FDA and the company received several reports of the wiring inside the device overheating, which led to wires near the cartridge of the device to melt and cause smoke, which could then be ingested by a patient. Breathing the toxic fumes could result in serious health risks to patients, including death.

Affected units were said to be distributed to patients between March 19, 2012 and October of the same year. Anyone in possession of an affected unit has been instructed to contact the manufacturer of the device immediately.

The Ohio Personal Injury Lawyers with Nurenberg, Paris, Heller & McCarthy recognize the dangers of defective products and acknowledge the importance of contacting experienced product liability lawyers if you have been caused harm by the use of a medical device that has been deemed defective.