FDA labels eVent Medical ventilator recall as Class 1

The FDA released a recall notice yesterday for eVent Medical’s LS, 5i and 7i Inspiration ventilators over an issue with faulty switches on the power board that can fail and cause a system shut down without an alarm.

If the devices shut down without warning, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

The recall affects 251 units manufactured before January 21, 2015 and distributed between February 14, 2013 and December 31, 2014, according to the FDA.

The federal watchdog said eVent Medical received 1 report of the error with the faulty switch and shut down occurring, though there were no injuries or deaths reported from the incident.

The FDA said eVent Medical sent an urgent field safety notice to customers with the devices on October 13 advising them to discontinue use with the ventilators until the issue was addressed, and attached instructions for removing the potentially faulty component.

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