In March, Draeger told customers of the 3,713 machines to test the device’s batteries and return any products with malfunctioning batteries. Four incidents, zero injuries and zero deaths have been reported, according to the FDA.
If the battery suddenly dies while in use, there might be an unexpected shutdown without a low battery alarm, and patients could face hypoventilation or hypoxia.
This is a product correction, not a product removal, the FDA said.
