Dräger, Covidien Recall Ventilators

September 4, 2015

Dräger Medical and Covidien are recalling more than 2,700 ventilators over potentially fatal issues.

The FDA has given Class 1 recall status to more than 2,000 Evita V500 and Babylog VN500 ventilators manufactured and distributed from June 2011 to June 2015 by Dräger over concerns about faulty batteries. Both ventilators provide breathing support for premature babies weighing at least 14 ounces. The Evita model also may be used in children and adults.

As the FDA notes in a post from last week, the ventilator batteries do not last as long as expected, and the indicator light shows sufficient charge even when the battery is depleted. If a ventilator were to shut down, a patient may not receive enough oxygen, leading to potential injury or death.

The company sent an urgent medical device recall letter on July 13 to customers informing them that it plans to replace faulty batteries. Until the batteries are replaced, it advised customers not to rely on the battery status indicator, connect the ventilator to a main power supply if the power alarm sounds and not use the device to transport patients unless necessary.

Covidien Recall

The agency also announced a Class 1 recall of 657 of Covidien’s Puritan Bennett 980 ventilators, produced and distributed between March 2014 and June 2015, over a potential software glitch. The ventilators provide breathing support for premature babies weighing at least 10.6 ounces through adults.

When set to neonatal volume control plus mode with active humidification, the software glitch may cause the amount of air being delivered to be lower than the programmed amount.

The malfunction could result in injury or death.

Covidien sent an urgent field corrective action notice to customers informing them that it intends to implement a software update to correct the error.

Read the Dräger recall notice here: www.fdanews.com/09-08-15-drager.pdf and the Covidien recall notice here: www.fdanews.com/09-08-15-covidien.pdf. — John Bechtel