Backup batteries for GE Healthcare’s CARESCAPE R860 ventilator, which is intended to provide mechanical ventilation or breathing support, were recalled because the batteries may run out before they are expected to do so.
The U.S. FDA has identified this as a Class I recall, the most serious type of recall. Use of these may cause serious injuries or death. 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.
Lack of oxygen (hypoxia), especially if it occurs over a long period, can cause serious injury and death.
The CARESCAPE R860 ventilator provides mechanical ventilation or breathing support to infants, children, and adult patients weighing 0.25 kg and above. It uses main AC power via a wall plug to operate, though, 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.
The recall specifies products that were distributed from April 2, 2019 to April 18, 2022. There were 4,222 devices recalled in the U.S.
There have been 1,553 complaints, no injuries, and no deaths associated with the use of this device.
Earlier this year, GE Healthcare issued an Urgent Medical Device Correction letter to customers. The letter recommended that customers and/or users:
- Perform a Battery Performance Test (described under Appendix A of the correction letter):
- Immediately after receiving the device correction letter
- Every 3 months
- Before using if the device has been in storage for more than 3 months
- Continue to use the affected ventilators while the ventilator is connected to an AC mains power source that is supported by backup emergency power.
- If use of the ventilator by battery power is necessary, for example during transport where alternative options are limited, follow standard clinical practice when it comes to administering the appropriate readily accessible alternative ventilation, such as abag-valve system.
- Replace the batteries when necessary, before patient use.
- Keep the ventilator connected to the AC main power source when it is not in use, even when it is in storage. This will prevent battery discharge and degradation.
- Replace backup batteries at a minimum of every three years.