 |
| Inspiration 5i Ventilator--Courtesy of eVent Medical |
eVent Medical is recalling the LS, 5i and 7i Inspiration ventilators because of a faulty switch on the ventilator's power board may fail, causing the device to shut down without sounding an alarm, according to the FDA's latest safety alert. The recalled devices are all models of the ventilators manufactured prior to Jan. 21, 2015, or 6,441 units around the world, including 251 distributed in the U.S.
"If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death," the FDA said in the alert.
The agency said Lake Forest, CA's eVent Medical received one report of the issue occurring, though there were no deaths or injuries.
In November, the agency deemed the recall Class 1. That's the most severe category, and reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
In October, eVent sent out an urgent field safety notice advising customers to immediately discontinue use of the affected ventilators until corrective actions can be taken, according to the FDA. Included in the notice were instruction for removing the removing the potentially faulty component from the power board.
The firm issued a less severe Class 2 recall in 2005, according to the FDA database.
The FDA's decision to publicize the recall via a safety alert instead of its somewhat obscure database should raise awareness of the issue and shows that agency is concerned about the problem.
eVent's recall adds to a growing body of Class 1 recalls plaguing ventilators, including those made by Hamilton Medical, CareFusion, Covidien and Philips Respironics.
There were 5 Class 1 recalls of continuous ventilators in 2015 and 9 in 2014, as well as 10 less serious Class 2 recalls over the two years, according to the FDA database. The most commonly report problem is the display of an error message, following by incorrect or inadequate test results, malfunction and device inoperability.
- read the safety alert
- here's more from the FDA's recall database