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Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator Due to a Nonconforming Battery Charger, Which Triggers a Battery Alarm and Renders the Ventilator Inoperable
Baxter Healthcare Corporation is correcting the Life2000 Ventilator System due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable. This is a result of a failed crimping operation during manufacturing that caused the crimp to puncture the insulation of the charger connector, thus resulting in an audible and visual alarm, which when engaged makes the ventilator inoperable. The alarm is a high-pitched sound with repetitive beeping and a visual red flashing LED icon, alerting the user to an issue with the device. Baxter has corrected the issue, and a Baxter representative will provide a replacement charger as well as arrange for the return of the defective battery charger.
The use of affected product may cause serious adverse health consequences, including deterioration in respiratory status, leading to hypoxia (lack of oxygen), with resulting cognitive impairment (confusion), lethargy, changes in blood pressure and heart function, or even coma and death.
If the patient is not quickly transitioned to an alternate means of ventilation or oxygen therapy, further lung damage could occur depending on the user’s pre-existing medical condition and access to their recommended back-up device or oxygen therapy.
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with questions about this recall should contact Baxter Advanced Respiratory, Home Care Customer Service team at 800-426-4224, option 3, between the hours of 7:30 a.m. and 6:00 p.m. Central Time, Monday through Friday. Alternatively, contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071.
Health care providers with questions about this recall should contact Baxter Advanced Respiratory team at 800-426-4224, option 2, then option 1, between the hours of 8:00 a.m. and 6:00 p.m. Central Time, Monday through Friday.
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