The U.S. Food and Drug Administration (FDA) recently issued an immediate recall of Dräger Evita V500, Babylog VN500 ventilators, as well as PS500 batteries due to unexplained mechanical problems with these defective medical devices.
Chicago attorney Gregory F. Coplan of Coplan & Crane praised the FDA's actions, which went into effect immediately in March 2016. "There's no room for error when it comes to defective medical devices," Coplan said. "If a patient's ventilator stops working, the consequences can be catastrophic."
Specifically, the ventilators continue to have mechanical problems, which cause them to shut down without warning, putting patients at risk of serious health problems or even death, according to the FDA recall issued in March 2016.
The FDA initially recalled the Evita V500 and Babylog VN500 in December 2015 due to such mechanical problems. Dräger Medical, the German-based manufacturer of the devices, updated the software for the ventilators. But the new software "failed to correct the issue," according to the FDA. As a result, the FDA announced in March 2016 announced it was issuing a Class I recall for these devices. Class I is "the most serious type of recall," the FDA states.
The March 2016 Class I recall affects 2,501 ventilators manufactured by Dräger Medical between June 1, 2011 and Dec. 1, 2015. The Babylog VN500 was designed to help premature babies breathe who weigh more than 14 ounces. The Evita V500 device assists adults and children who cannot breathe on their own.
In an effort to correct this mechanical problem, Dräger Medical will replace the PS500 Optional Power Supply units, which cause the ventilators to stop working without warning. Patients who suddenly cannot breathe can suffer a wide range of serious or fatal health problems from lack of oxygen.
Without oxygen, people can suffer permanent brain damage in as little as 4 minutes, according to the National Institutes of Health. Death is also a very real danger if a patient's ventilator suddenly stops working.
An estimated 22,000 people each year are killed due to defective products, according to the U.S. Consumer Product Safety Commission. Worst of all, many of these deaths could have been prevented, according to Chicago attorney Benjamin A. Crane of Coplan & Crane.
"If companies simply spent more time and care to test their products, many of these injuries or fatalities caused by defective products would not occur," Crane said. "That's why the FDA exists - to make sure that companies comply with the rules and regulations established to protect people from dangerous medical devices or drugs. And when these companies fail to play by the rules, they need to be held accountable for their actions."