Baxter Recall Life2000 Ventilators with Attached Battery Charger DongleBaxter Recall Life2000 Ventilators with Attached Battery Charger Dongle
The company said that if damaged, the battery charger dongle is unable to charge the ventilator’s internal battery which could lead to an inability to use the device.
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Baxter International recently announced an Urgent Medical Device Recall for its Life2000 ventilators with an attached battery charger dongle after reports that the dongle doesn’t charge properly when damaged.
The company informed customers that when damaged, the battery charger dongle is unable to charge the ventilators internal battery. If it fails to charge, a patient would not be able to use the device. For patients requiring Life2000 support, an inability to use the device could result in oxygen desaturation episodes that range from mild to potentially life-threatening.
Baxter advised patients to have an alternate ventilator or oxygen therapy device available. Patients and healthcare providers are being instructed to inspect the condition of the battery charger dongle to confirm it is charging correctly. If damaged, patients should contact Baxter customer service to have the device replaced immediately.
If the ventilator is not seen to have any charging issues, the company said that the device can continue to be used until the patients’ next scheduled in-home visit, where it will be replaced.
The recall applies specifically to the Life2000 ventilator with product code MS01-0118 with an attached battery charger dongle. The product impacted by the recall was distributed in the US between Aug.21, 2023, and April 2, 2024. Currently, Baxter has received one serious injury complaint potentially related to the issue.
This recall comes after an early 2023 Urgent Medical Device Correction for its Life2000 ventilators due to risk of patient oxygen desaturation when connected with a third-party oxygen concentrator.
As part of the correction, the company said that patients could continue using the system if they followed daily checks and preventative maintenance requirements as detailed in the patient letter and instructions of use for both the Life2000 and third-party oxygen concentrators. Continuing these actions, according to Baxter, would help ensure the system delivers optimal oxygen when used with a third-part oxygen concentrator.
Additionally, in 2022, Baxter also announced a Class 1 recall of its Volara ventilator after receiving reports of two device-associated deaths.
Baxter referred MD+DI to the recall announcement and declined to answer any additional questions.
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