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FDA Issues Class I Recall for Ventilators that May Shut Down Without Alarm

FDA Issues Class I Recall for Ventilators that May Shut Down Without Alarm

The U.S. Food & Drug Administration has alerted the public of a Class I recall of eVent Medical’s LS, 5i, or 7i Inspiration Ventilators due to the fact that they may shut down without alarm. A ventilator is a machine used in hospitals or other healthcare settings that mechanically blows air into a patient’s airways and lungs for patients who are unable to breathe sufficiently or naturally. Essentially, it is a machine that breathes for you.

The Recall

The manufacturer eVent Medical recalled all models of its LS, 5i, and 7i Inspiration ventilators manufactured prior to January 21, 2015 and distributed from February 14, 2013 to December 31, 2014, after receiving a report that one of its machines shut down without an alarm to alert healthcare providers it had failed. The company has identified that the recalled machines may have a faulty switch on the ventilators’ power board, causing it to fail and shut down without alarm. The company first initiated the recall and alerted healthcare providers on October 13, 2015.

The FDA’s Response

The FDA has categorized the recall as a Class I recall, which is the most serious type of recall, because it cause serious injury or death. According to the FDA, “if the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.”

The Scope of the Recall

Approximately 251 units have been recalled nationwide. For more information, call the defective device attorneys at Shrader & Associates by clicking here.


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