Medical Device Safety and Recalls: Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries

A recall has been issued for the Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries
. The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted.

When the “battery low” and “battery depleted” alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery back-up should last until the ventilator is connected to a main power supply.

If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

FDA.gov

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