FDA Class 1 Recall: GE Healthcare’s CARESCAPE R860 Ventilator
The FDA has released a a Class I recall for GE Healthcare’s CARESCAPE R860 Ventilator. Use of these devices may cause serious injuries or death.
GE Healthcare has recalled the device due to early failure of backup batteries, that may cause unexpected ventilator shut down.
Recalled Product
· Product Name: CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator backup batteries and replacement backup batteries manufactured on or after April 1, 2019.
· Product Model Numbers: See recall database entries:
· Backup batteries in CARESCAPE R860 ventilators, manufactured on or after April 1, 2019
· Replacement backup batteries for CARESCAPE R860 ventilators, manufactured on or after April 1, 2019
· Devices Recalled in the U.S.: 4,222
· Dates distributed: April 2, 2019, to April 18, 2022
· Date Initiated by Firm: April 18, 2022
Device Use
The CARESCAPE R860 ventilator is intended to provide mechanical ventilation or breathing support to infants (neonatal), children (pediatric), and adult patients weighing 0.25 kg and above.
The CARESCAPE R860 ventilator uses main 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.
Reason for Recall
GE Healthcare is recalling CARESCAPE R860 ventilator backup batteries, including replacement backup batteries, manufactured on or after April 1, 2019, because the batteries may run out before they are expected to do so. 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.
There have been 1,553 complaints, no injuries, and no deaths associated with the use of this device.
Who May Be Affected
· Health care personnel who use Carescape R860 ventilators to support patient breathing
· People who receive breathing support using a Carescape R860 ventilator
What to Do
On April 18, 2022, 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):
o Immediately after receiving the device correction letter
o Every 3 months
o 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.
