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.
