Medical Device Safety and Recalls: Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 06 Jan 2016 09:24:59 -0600

Title:     Medical Device Safety and Recalls: Dräger Evita V500 and Babylog VN500 Ventilators - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly

  A recall has been posted regarding Dräger Evita V500 and Babylog VN500 Ventilators.  Dräger is recalling the PS500 battery power supply because a software issue causes shorter than expected battery run times.  The software issue with the power supply also prevents the appropriate alarm from sounding 5 minutes before the battery runs out of power and the device shuts down.  If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

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