FDA Class I Recall: Batteries for CARESCAPE 2860 Ventilator

Maiya Focht

Disclosures

June 28, 2022

Editor's Note July 5, 2022 // This article has been corrected (first paragraph) per an FDA announcement to clarify that there have been no deaths or injuries associated with the use of this device. A previous version reported that a product error led to one injury.

The US Food and Drug Administration (FDA) has issued a Class I Recall for the CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator batteries. A total of 1533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.

Healthcare personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.

This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations like power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.

However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.

In order to prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should also take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should also be replaced at a minimum of every 3 years.

When these devices are still plugged into the wall, they're safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.

There are 4222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019 through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA's MedWatch database or by sending a medical device notification acknowledgement response to GE at the email address listed at the bottom of the recall announcement.

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