Life Pulse Ventilator Recall Due to Risk of Failure, Fires
A nationwide recall of high frequency ventilators for infants has been issued following reports of insulated heater wires melting, causing the device to spark and smoke close to the humidifier cartridge, which may pose a risk of injury and even death for patients.
The Bunnell Inc. Life Pulse High-Frequency Ventilator Patient Circuits recall was announced by the FDA and the manufacturer on Wednesday, following 12 reported failures of heater due to wire insulation melting.
The recall affects an estimated 5,771 ventilators sold nationwide. The ventilator is an off-white color in the shape of a box with control panels on the front that allow for temperature adjustment and other readings. The ventilator reads “Life Pulse” and “High Frequency Ventilator” in blue lettering at mid-level of the machine
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The high frequency ventilators are used for early therapeutic intervention and treatment of pulmonary interstitial emphysema and other volutrauma induced lung injury. The machine produces small, high velocity jets of air at fast rates to oxygenate patients with early onset breathing troubles.
No particular cause for the melting wires has been determined, but Bunnel released a notice that explained environmental factors may affect the circuits ability to maintain the set circuit temperature. For example, if a ventilator is stationed closely to an air conditioning vent it may cool the circuits causing the temperature to decrease and forcing the machine work harder, thus causing the heater wires to overheat.
Over humidification at one hospital was found to cause the circuit to fail because the excess moisture accumulated at the thermister and lowered the measured circuit temperature causing the heater wires to work harder to maintain the set temperature. This is very hazardous because once the insulation melts, a short in the heater wires generates excess heat causing the tube to melt.
No injuries have been reported but Bunnell is working closely with the FDA to resolve the issue and will be notifying customers via certified mail. Customers with questions can contact Bunnell at (800) 800-4358, or visit the company’s website at www.bunl.com.
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