Near the end of December, Baxter Healthcare Corporation issued an urgent correction for four models of their Life2000 Ventilator. According to the FDA, the correction pertains to a malfunction with the battery charger for the device.
Baxter’s Life2000 Ventilator is a mask-free, portable unit designed to provide assistance to patients who are unable to breathe sufficiently on their own. The device delivers oxygen to the lungs while simultaneously removing carbon dioxide. Baxter announced the recall on December 20th via an Urgent Medical Device Correction letter, which they sent to customers and health care facilities. The company attributes the recall to a faulty battery charger, which they say triggers the battery alarm for the device and renders the ventilator unusable. Baxter says that a manufacturing problem damaged the insulation on the charger. That damage is at fault for the battery alarm issues.
Connecting the Life2000 Ventilator to the battery charger while in use will stop the device from functioning, which will result in an interruption to the patient’s ventilation therapy. Such an interruption is likely to result in oxygen deprivation, which can then cause “cognitive impairment (confusion), lethargy, changes in blood pressure and heart function, or even coma and death.” While no injuries or deaths have been reported thus far, continued use of the Life2000 Ventilator with the original battery charger presents serious risks for patients receiving ventilation support.
The model numbers for the Life2000 Ventilator devices included in the recall are as follows:
- REF BT-20-0002 | UDI/DI 00887761978201
- REF BT-20-0002A and REF BT-20-0002AP | UDI/DI 00887761981638
- MS-01-0118 | UDI/DI 00887761978089
- MS-01-0118 | UDI/DI 00815410020537
In its notification letter, Baxter urged users to always have a back-up ventilator on hand in case of issues. Additionally, they pledged to correct the problem by replacing the faulty battery charger with a new charger that will not cause malfunction with the ventilator. Baxter asks that all customers acknowledge receipt of the correction notice via the instructions provided in the letter.
Anyone with questions or concerns about the recall can contact Baxter Healthcare Corporation at 800-426-4224 (option 3), Monday through Friday from 7:30 a.m. to 6:00 p.m., CST.
Patients and health care providers can report any new adverse health events related to Baxter Healthcare Corporation’s Life2000 Ventilator through the FDA’s MedWatch Online Voluntary Reporting Form.
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