FDA: Class I recall of Inspiration LS, 5i, and 7i ventilators

Editor's Note

The Food and Drug Administration on December 7 categorized the recall of Inspirtion LS, 5i, and 7i ventilator systems manufactured before January 21, 2015, by eVent Medical (Lake Forest, California) as Class I, the most serious.

The recall was initiated because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm.

The company received one report of this issue occurring, with no injuries or deaths.

Posted 12/07/2015] AUDIENCE: Risk Manager ISSUE: 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.