Faulty Switch Could Cause eVent Inspiration Ventilator to Shut Down without Sounding Alarm, Endangering Patient

The medical device maker eVent Medical has recalled 215 LS, 5i, or 7i Inspiration ventilators because of a faulty switch on the power board. The switch can fail and shut down the ventilator with sounding an alarm.

If the ventilator shuts down without sounding an alarm to alert those responsible for operating the ventilator, 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). Because of the seriousness of the risk to the patient, the FDA has categorized this as a Class 1 recall, the most serious recall category.

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

This recall covers all models of LS, 5i and 7i Inspiration ventilators made by eVent Medical before January 21, 2015. The recalled ventilators were distributed nationwide from February 14, 2013 to December 31, 2014. The company has received one report of the shutdown problem occurring, but no reports to date of injuries or deaths.

The FDA recall announcement said eVent had sent an urgent field safety notice on October 13, 2015 informing customers of the possible shutdown problem with the Inspiration ventilators. The company advised customers to stop using the affected ventilators until corrective actions could be taken. The letter included instructions for removing the potentially faulty component from the power board. Customers with questions about the recall can call eVent customer service at  949- 900-1917.

The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of the ventilators to the MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.

 

from Parker Waichman http://www.yourlawyer.com/blog/faulty-switch-could-cause-event-inspiration-ventilator-to-shut-down-without-sounding-alarm-endangering-patient/