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FDA Warns About Possible Ventilator Shut-Down
Dräger is recalling the PS500 — an optional battery power supply sold for use with the Dräger Evita and Babylog ventilators — because a software issue causes shorter-than-expected battery run times, the FDA says.
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.
According to a notice posted by the FDA, the software issue with the PS500 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, which could result in 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.
Dräger sent a letter to all customers with affected devices in December 2015, informing them of this issue. The letter indicates that Dräger will contact customers with affected devices to update battery-charging software and will replace batteries, if necessary, free of charge.
Source: FDA; January 6, 2015.