Baxter Healthcare is recalling Life2000 ventilators due to potential charging failures caused by damage to the battery charger dongle.
RT’s Three Key Takeaways:
- Recall Due to Charging Issues: Baxter Healthcare is recalling its Life2000 ventilators because certain systems may fail to charge or exhibit intermittent charging due to damage to the battery charger dongle, which prevents the internal battery from charging.
- Urgent Notifications and Instructions: Starting May 29, Baxter notified patients, healthcare providers, wholesalers, and distributors through an urgent medical device recall letter, instructing them to ensure alternative ventilator or oxygen therapy is available, inspect the dongle for damage, and replace it if necessary.
- FDA Classification and Actions: The FDA has classified this recall as a Class I recall, the most serious type, involving 2,510 units. Healthcare providers and distributors were instructed to observe alarms, notify Baxter for assistance, arrange for product returns, and acknowledge receipt of the recall notification.
Baxter Healthcare is recalling its Life2000 ventilators due to the potential for certain ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle, according to a recall notice from the US Food and Drug Administration (FDA).
Damage of the battery charger dongle prevents the ventilator’s internal battery from charging.
The Life2000 ventilator is a mask-free non-invasive ventilator designed to provide breathing support to patients at home.
Baxter began notifying consignees on May 29 via an urgent medical device recall letter. Patients, healthcare providers, wholesalers, and distributors were instructed to ensure patients always have an alternate means of ventilator or oxygen therapy available, inspect the battery charger dongle for damage, and replace immediately if damaged.
[Further reading: Baxter Issues Device Correction for Life2000 Ventilator]
Patients may continue to use the ventilator system once they inspect and confirm no damage to the dongle and the battery is charging appropriately, according to Baxter. Patients were instructed to observe any alarms from the ventilator system and to contact Baxter Home Care Customer Service for assistance. Baxter will replace their ventilator device during their next scheduled in-home visit with a clinical trainer. Patients were also asked to acknowledge receipt of the notification letter.
Healthcare providers, wholesalers, and distributors were requested to observe any alarms of the ventilator system and notify Baxter Acute Care Customer Service Support, 800-426-4224, option 2, for any assistance, arrange for the return of any impacted product, and to acknowledge receipt of the letter. Additionally, they were asked to notify customers if further distributed.
The FDA has identified the recall as a Class I recall, the most serious type. The recall involved 2,510 units.
Photo caption: Life2000 ventilator
File photo
