Evita V500 and Babylog VN500 Ventilators by Dräger: Class I Recall - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly

AUDIENCE: Risk Manager, Surgery, Critical Care Medicine, Nursing, Pediatrics

ISSUE: 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.

The recalled device is the optional PS500 battery power supply for Dräger Evita V500 and Babylog VN500 ventilators, manufactured from June 1, 2011 to October 30, 2015 and distributed from June 1, 2011 to October 30, 2015. See the Recall Notice for further information, including catalog numbers and pictures.

BACKGROUND: The PS500 is an optional battery power supply sold for use with the Dräger Evita and Babylog ventilators. The Evita V500 Ventilator provides constant breathing support for adults and children, including premature babies weighing at least 14 ounces. The Babylog VN500 provides constant breathing support for premature babies weighing at least 14 ounces. Both ventilators are used in hospitals or during patient transport.

RECOMMENDATION: Dräger sent a letter to all customers with affected devices on December 3, 2015, informing them of this issue. The letter indicates that Dräger will contact customers with affected devices to update battery charging software, and replace batteries if necessary, free of charge.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm480231.htm