FDANews
The QMN Weekly Bulletin

Dräger Recalls 2,422 Units of its Battery Power Supply

March 4, 2016

Dräger is recalling 2,422 units of its PS500 battery power supply in the U.S.

A software issue leads to shorter than expected battery run times and prevents the appropriate alarm from sounding five minutes before the device shuts down.

The recall was deemed Class 1 by the FDA, as a patient may not receive necessary oxygen if the device shuts down.

The optional battery power supply is sold for use with the Dräger Evita, designed for breathing support for children and adults, and Babylog ventilators, built for premature babies weighing at least 14 ounces. Distribution dates for affected products are June 1, 2011 through Oct. 30, 2015.

Dräger notified customers of the issue in a letter on Dec. 3, 2015, and indicated it would contact them about updating the battery charging software and, if necessary, replacing the batteries.

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