Recall for Ventilators that Could Shut Down without Sounding Alarm, Endangering PatientDec 7, 2015
A recall has been issued for LS, 5i, or 7i Inspiration ventilators made eVent Medical. A faulty switch on the power board may fail, causing the ventilator to shut down without sounding an alarm.
If the ventilator unexpectedly shuts down without sounding an alarm to alert those caring for the patient, 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). For this reason, the FDA has categorized this as a Class 1 recall, the most serious of the three device recall categories.
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 215 recalled ventilators were distributed nationwide from February 14, 2013 to December 31, 2014. The company said it has received one report of the shutdown problem occurring, but no reports to date of injuries or deaths.
The recall announcement said eVent sent customers an urgent field safety notice on October 13, 2015 informing them of the possible shutdown problem with the Inspiration ventilators. The company advised customers to immediately stop using the recalled ventilators until corrective actions could be taken. The letter included instructions for removing the potentially faulty component from the power board. Customers with questions were told to call eVent customer service: (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.