Drager has issued a recall for its PS500 battery power supply used to power its Evita V500 and Babylog VN500 ventilators manufactured and distributed between June 1, 2011 and October 30, 2015. According to a U.S. Food and Drug Administration (FDA) recall notification dated Jan. 6, 2015, the recall is due to a software problem that results in shorter than expected battery run times. Additionally, it stops an appropriate alarm from sounding 5 minutes before the battery runs out of power and the ventilator stops working. Patients may receive inadequate oxygen and die if ventilation shuts off.
The FDA designated the recall as Class I, the agency’s most serious recall status. Class I recalls are reserved for situations where exposure to a recalled device presents a reasonable risk of serious injury or death.
The Evita V500 Ventilator provides constant respiratory support for adults and children. According to the FDA, it can also be used in premature babies who weigh at least 14 ounces. The Babylog VN500 is used in premature babies who weigh a minimum of 14 ounces. The PS500 is an optional battery supply that can be used in these two ventilators, which are used in hospitals and during patient transport. On December 3, 2015 Drager sent a letter to customers notifying them of the issue. Customers were instructed to update battery charging software and replace batteries if necessary.