Baxter Recalls Life2000 Ventilator Over Battery Charging Failure

Baxter has recalled its Life2000 ventilator. This recall was classified as the most serious type by the U.S. Food and Drug Administration and involves removing some devices from where they’re used or sold.

The company recalled the Life2000 system over the battery charging dongle’s potential to fail. This can stop the system from charging or only allow intermittent charging.

Using the affected products can cause desaturation episodes if the ventilator stops running or runs intermittently because of a low battery. The episodes can range from mild to possible life-threatening. They can even cause death if the patient is critically ill.

So far there has been one reported injury due to the issue, with no reports of death.

Baxter advised in its May 29 Urgent Medical Device Recall letter to check that the ventilator battery charge icon is shown on the touch screen during charging from low battery state, to ensure the battery is charging the ventilator. Any alarms should be observed and Baxter’s Acute Care customer service support contacted for assistance with any alarms.

The system’s Quick Reference Guide should also be reviewed for more details about the approximate ventilator battery charge, time remaining, and associated alarms.

If damage is found on the charging dongle or the system fails to charge as expected, Baxter advised immediate contact to obtain a replacement. Baxter said replacements will be provided after starting the process to return affected products.

More about the Life2000 Ventilation System

The system provides continuous or intermittent ventilatory support for those needing mechanical ventilation assistance. It delivers positive pressure ventilation through a tube inserted into the trachea (endotracheal) or through a mask placed over the face.

It can also deliver assist/control ventilation. It is used in both home and health care settings.