The backup batteries of the CARESCAPE R680 system could run out earlier than expected, prematurely shutting down the machine and cutting off breathing support for patients.
Potential harm from faulty batteries leads to recall of over 4,000 GE ventilators
July 01, 2022
by John R. Fischer, Senior Reporter
GE Healthcare is recalling more than 4,000 of its CARESCAPE R860 ventilators due to an issue with its backup batteries that may be potentially deadly.
The CARESCAPE R860, which provides breathing support to infants, children, and adult patients, has backup batteries that may run out earlier than expected, according to the FDA. This could cause the device to prematurely shut down.
“If the ventilator shuts down, a patient may not receive necessary oxygen. If this goes unnoticed and untreated, it may be life-threatening,” wrote GE Healthcare in a letter it issued in May about the recall.
The batteries at issue were distributed between April 2019 and April 2022, and affect 4,222 ventilators, according to GE. They are meant to be an alternative source of power for when the device is not plugged into the wall.
The FDA has named it a Class I recall, the most serious type, and says there have been 1,553 complaints related to its use but no reported injuries, according to Reuters.
The company is advising users with affected machines to keep the ventilators on main power whenever possible and only switch to battery power when “absolutely necessary". They should also have alternative ventilation options ready in case batteries stop working.
EDIT 7/1: An earlier version of this story said that the battery issue resulted in one known injury. This was due to an error in the initial FDA alert. To date, there are no known injuries connected to the issue.
The CARESCAPE R860, which provides breathing support to infants, children, and adult patients, has backup batteries that may run out earlier than expected, according to the FDA. This could cause the device to prematurely shut down.
“If the ventilator shuts down, a patient may not receive necessary oxygen. If this goes unnoticed and untreated, it may be life-threatening,” wrote GE Healthcare in a letter it issued in May about the recall.
The batteries at issue were distributed between April 2019 and April 2022, and affect 4,222 ventilators, according to GE. They are meant to be an alternative source of power for when the device is not plugged into the wall.
The FDA has named it a Class I recall, the most serious type, and says there have been 1,553 complaints related to its use but no reported injuries, according to Reuters.
The company is advising users with affected machines to keep the ventilators on main power whenever possible and only switch to battery power when “absolutely necessary". They should also have alternative ventilation options ready in case batteries stop working.
EDIT 7/1: An earlier version of this story said that the battery issue resulted in one known injury. This was due to an error in the initial FDA alert. To date, there are no known injuries connected to the issue.