Faulty Power Switch Sparks eVent Medical Recall of Inspiration Ventilators
eVent Medical has implemented a Class 1 recall of its Inspiration ventilators, citing a faulty switch on the power board that may fail, causing the device to shut down without sounding an alarm.
The ventilator systems provide constant breathing support to infants and adults. eVent received one report of the ventilator shutting down without sounding an alarm, but there were no injuries or deaths, the FDA says.
The nationwide recall, which involves 251 units, affects all LS, 5i and 7i models manufactured prior to Jan. 21, 2015, with distribution dates of Feb. 14, 2013, to Dec. 31, 2014.
The company sent an urgent field safety notice to all customers on Oct. 13, 2015, advising them to immediately discontinue use of the ventilators until corrective actions could be taken, according to a recall notice issued Dec. 7 by the FDA.
“To mitigate the risk of ventilator failure, the firm attached the instructions for removing the potentially faulty component from the power board,” the FDA says.
eVent did not respond to a request for comment by press time.
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