Class 1 Recall for eVent Ventilators: Ventilator May Shut Off without Sounding Alarm

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Medical device maker eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm.

If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death, according to the Food and Drug Administration (FDA). The FDA has identified this as a Class 1 recall, the most serious type of recall.  Use of these ventilators could result in serious injury or death.

The Inspiration LS, 5i and 7i ventilator systems provide constant breathing support for infants and adults. The ventilator is used in hospitals or health care facilities.

This recall includes all models of eVent Medical LS, 5i and 7i Inspiration ventilators manufactured before January 21, 2015. The 215 recalled ventilators were distributed nationwide from February 14, 2013 to December 31, 2014. The company received one report of this issue occurring, with no reports of patient injuries or deaths.

The firm sent an urgent field safety notice to all customers on October 13, 2015 informing them of this issue. The company advised customers to immediately discontinue use of the recalled ventilators until corrective actions could be taken. Customers with questions are instructed to call eVent customer service: (949) 900-1917. The letter included instructions for removing the potentially faulty component from the power board.

Health care professionals and patients may report adverse events or side effects related to the use of an eVent ventilator to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.

 

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