Dräger is recalling the PS500 battery power supply for its ventilators 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 five 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 PS500 is an optional battery power supply sold for use with the Dräger Evita and Babylog ventilators, manufactured from June 1, 2011 to October 30, 2015 and distributed from June 1, 2011 to October 30, 2015. There were 2,422 units total distributed to multiple states.
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.
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.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, August 2015 Report: Pediatrician Liability Involving Diseases and Conditions of Childhood
See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability Risks
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe