The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Optional PS500 battery power supply for Dräger Evita V500 and Babylog VN500 ventilators, manufactured from June 1, 2011 to October 30, 2015.
- Catalog numbers: 8416400 - 8417400
- Distribution Dates: June 1, 2011to October 30, 2015
- Devices Recalled in the U.S.: 2,422 units total were distributed to multiple states
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.
Images of the Evita V500 ventilator (left) and Babylog VN500 ventilator (right)
Reason for Recall
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.
Who may be affected
- Health care providers using the PS500 battery power supply with Dräger Evita V500 and Babylog VN500 ventilators.
- All patient groups who may be given breathing support with ventilators using this power supply.
What to Do
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.
Customers with questions are instructed to call Dräger technical support: 1-800-543-5047
Date Recall Initiated
December 1, 2015
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.