Baxter Life2000 Ventilators Recalled Due to Low Gas Pressure Alarm Malfunction

The FDA has identified a recall of Baxter Life2000 ventilators as the most serious type.

The agency urges users to “make sure that the Life2000 ventilator is connected to a pressure gas source (Life2000 compressor, oxygen cylinder or wall source) that is turned on before starting ventilator therapy.” This follows a letter sent by Baxter in September recommending the same.

The FDA also asks home care users / patients and healthcare providers and patients to “acknowledge receipt of the notification.”

Baxter is updating its instructions for the ventilator because the “ventilator may fail to issue a Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not connected to the ventilator and turned on before starting therapy. The firm is currently working on a software update to address this issue and will contact all impacted customers to update their devices once the update is available.” This could lead to “serious adverse health consequences, including shortness of breath, a drop in oxygen levels (desaturation), and death. There has been one reported injury. There have been no reports of death.”

The Life2000 Ventilation System is used “to provide continuous or intermittent breathing (ventilatory) support for people who require mechanical ventilation assistance. The system delivers positive pressure ventilation through a tube inserted into the trachea (endotracheal) or through a mask placed over the face.”