GE Healthcare is recalling CARESCAPE R860 ventilator backup batteries manufactured on or after April 1, 2019, because the batteries may run out before they are expected to do so.
The CARESCAPE R860 ventilator is intended to provide mechanical ventilation or breathing support to infants, children, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator uses AC power via a wall plug to operate. However, there is also a backup battery that is intended to keep the ventilator operating for a certain amount of time if a main AC power supply is not available, for example during a patient transport. Replacement backup batteries are available from the company to use when the original backup battery expires.
If the ventilator is running on battery power only when the battery fails, ventilation could stop completely, preventing the patient from receiving oxygen and breathing support. The resultant hypoxia can cause serious injury and death. There have been 1553 complaints, 1 injury, and no deaths associated with the use of this device.
U.S. Food and Drug Administration (FDA). GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down. June 28, 2022. Available at: click here. Accessed June 28, 2022.