Urgent Medical Device Recall Issued for Ventilator

Bissued an urgent medical device recall for Life2000 ventilators that have a battery charger dongle attached on Wednesday after the company received a report of a serious injury.

Baxter recalled the fans due to reports that the devices did not charge properly when the battery charger dongle was damaged, according to an announcement posted on US Food and Drug Administration (FDA) website. The reported serious injury may be related to this issue, and the company said it is working with customers to replace fans that have this issue.

The recall applies to Life2000 ventilators with product code MS01-0118 that have the battery charger dongle attached and were distributed in the U.S. from August 21, 2023, through April 2, 2024, according to the recall announcement. The fan is normally used to help people who have conditions that can affect the respiratory system, such as chronic obstructive pulmonary disease (COPD), neuromuscular conditions such as amyotrophic lateral sclerosis (ALS), or restrictive chest disorders.

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The ventilator’s internal battery may not be able to charge if the battery charger dongle is damaged, according to the recall announcement. This could prevent patients from being able to use the device – and for some patients who require ventilators, it could cause episodes of oxygen desaturation that could be fatal. Baxter recommended that patients have alternative methods of ventilation or oxygen therapy available in case of emergency.

Baxter he said notified the FDA and affected customers of the issue. The company told affected customers to check the condition of the dongle to ensure the fan is charging properly. If customers notice damage or that the battery is not charging, they should contact Baxter Home Care Customer Service to have the fan replaced. If they do not notice any damage or the battery is charging as it should, the device can continue to be used safely; Baxter will replace the ventilator when patients have their next home visit with a clinical trainer.

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