USA – GE Healthcare has identified an issue nearly 117,000 batteries manufactured since April 1, 2019, in which they run out of power before they’re supposed to and initiated a global recall.
The US FDA has issued a notice labeling the recall of GE Healthcare’s Carescape R860 ventilator as Class I, the most serious kind.
GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so.
Carescape R860 uses main AC power via a wall plug to operate, but has a backup battery intended to keep the ventilator operating for a certain amount of time if a main AC power supply is not available.
An example of this occurrence would be a patient transport. Replacement backup batteries are available for use when the original backup battery expires.
If the loss of power occurs while a ventilator is running on the backup battery power, it could stop a patient from receiving necessary oxygen and breathing support, potentially leading to severe injuries or death.
To date, according to the FDA, GE Healthcare has received a total of 1,553 complaints related to the ventilators’ backup batteries. No injuries or deaths have been reported.
According to the FDA notice, the recall affected 4,222 devices in the US, all of which were distributed between April 2, 2019, and April 18, 2022 —the same day GE initiated the recall.
The recall spans more than 29,400 backup batteries distributed around the world for use with the Carescape R680 machines, plus more than 88,300 replacement backup batteries that were sold around the world to users of the Carescape machines and both Engström models.
Safety alert
GE Healthcare issued an urgent medical device correction letter to customers on that day, recommending that users perform a battery performance test immediately after receiving the correction letter, every three months and before using if the device has been in storage for more than three months.
The recall spans more than 29,400 backup batteries distributed around the world for use with the Carescape R680 machines, plus more than 88,300 replacement backup batteries that were sold around the world to users of the Carescape machines and both Engström models.
Users were also instructed to continue using the affected ventilators while the ventilator is connected to an AC mains power source supported by backup emergency power.
Additionally, the company advised that if use of the ventilator by battery power is necessary, such as during transport where alternative options are limited.
Users should follow standard clinical practice when it comes to administering the appropriately readily accessible alternative ventilation, such as a bag-valve system.
Batteries should be replaced when necessary before patient use and the ventilator should remain connected to the AC main power source when not in use, even in storage, to prevent battery discharge and degradation. Backup batteries should be replaced at a minimum of every three years.
Medical devices recall labelled as class I has been witnessed in the recent past. For instance, Minneapolis-based Medtronic recalled 1,614 pump implants developed for the company’s HeartWare ventricular assist device, which the FDA deemed a class I recall, the highest level, June 8.
The recall is due to a welding defect that could lead to corrosion and demagnetization of the internal magnets, potentially causing the pump to rotate incorrectly.
There have been one death and two injuries reported with the welding defect.
The HVAD system aids the heart in pumping blood throughout the body for patients in late-stage heart failure awaiting a transplant.
Medtronic notified physicians with an urgent medical device correction letter April 26 about the potential of a defect, according to the FDA.
In the last year alone, Philips, Covidien and Dräger have all recalled ventilators or related accessories from their respiratory portfolios.
GE Healthcare is now the latest to join the queue, but it moved swiftly and issued a safety alert in April for nearly 118,000 batteries used to provide backup power to some of its ventilators.
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