Safety Report: Baxter Life2000 Ventilator - recalled due to battery charger dongle damage, USA

United States

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. The impacted ventilators were distributed in the United States between Aug. 21, 2023 and April 2, 2024. Baxter has received one serious injury complaint potentially related to this issue.

The Urgent Medical Device Recall applies to the Life2000 ventilator with product code MS01-0118 with an attached battery charger dongle.

Damage to the battery charger dongle prevents the ventilator’s internal battery from charging. If the Life2000 ventilator fails to charge or has intermittent charging behavior, this may leave the patient unable to use the device. For patients requiring ventilator support, inability to use the device may result in oxygen desaturation episodes that range from mild to potentially life-threatening. Patients should always have an alternate means of ventilation or oxygen therapy available.

Baxter has contacted affected customers, instructing them to inspect the condition of the battery charger dongle and confirm the device is charging properly. If damage is observed or the battery is not charging properly, patients should contact Baxter Home Care Customer Service to have the device replaced immediately.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Baxter International, Inc.
Brand name: Baxter
Product recalled: Life2000 Ventilator with an attached battery charger dongle
Reason of the recall: Potential Battery Charger Dongle Damage

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-recall-life2000-ventilator-due-potential-battery-charger-dongle