December 1, 2015, Dräger initiated a recall of the PS500 Power Supply Unit, used with two models of ventilators, the Evita V500 and the Babylog VN500. The Dräger baby ventilator power supply unit recall was triggered by a software flaw in the battery power supply, in which the device may misinform the user of its amount of battery charge. In this case, the ventilator may deplete its battery, to the point that the machine turns off, in which case the patient may not receive necessary oxygen.
Since this risk is so dire, the U.S. Food and Drug Administration has identified this as a Class I recall, the most serious type of recall, because use of this device may cause serious injury or death.
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Dräger Baby Ventilator Power Supply Unit Recall Information
The PS500 Battery Power Supply is sold for use with the Dräger Evita and Babylog ventilators. The Evita V500 Ventilator and Babylog VN500 provide constant breathing support for premature babies.This recall only affects Evita V500 and Babylog VN500 ventilators equipped with the optional PS500 power supply unit.
Affected power supply units were manufactured from June 1, 2011 to October 30, 2015, and distributed nationally between June 2011 and January 2014. In the United States, 2,422 units are included in this recall.
