Summary: Baxter is recalling the Life2000 Ventilator System due to potential battery charging dongle failure, which can prevent or intermittently charge the system. This may cause serious health risks, including potentially life-threatening desaturation episodes. The FDA and Baxter recommend ensuring alternative ventilation methods and inspecting the charger dongle.

Key Takeaways:

  • Recall Reason: Baxter is recalling the Life2000 Ventilator System because the battery charging dongle may fail, preventing proper charging and causing potential serious health risks.
  • Health Risks: Failure of the ventilator can lead to desaturation episodes, ranging from mild to life-threatening, especially in critically ill patients.
  • Recommendations: Users should ensure alternative ventilation, inspect the charger dongle, and contact Baxter for replacements or assistance if issues are found.

Baxter is recalling the Life2000 Ventilator System due to the potential for failure of the battery charging dongle, which can prevent the system from charging or only allow for intermittent charging.

Health Consequences

Use of affected products may cause serious adverse health consequences, including a drop in oxygen levels (desaturation episodes) if the ventilator stops running or only runs intermittently due to a low battery. These desaturation episodes may range from mild to potentially life-threatening, or even cause death if the patient is critically ill.

There has been one reported injury. There have been no reports of death. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Recommendations from FDA and Baxter

As a result of the battery issue, the FDA and Baxter are recommending that users:

  • Make sure there is always another way available to provide ventilation or oxygen therapy.
  • Inspect the battery charger dongle for damage and make sure the battery is charging appropriately.
  • Continue use of the Life2000 ventilator once it is confirmed that there is no damage and the battery is charging as expected.

Urgent Medical Device Recall Actions

On May 29, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

  • Immediately contact Baxter Acute Care Customer Service Support at 800-426-4224, option 2, to obtain a replacement if damage is found on the charging dongle or if the Life2000 Ventilator System fails to charge as expected.
  • Check that the ventilator battery charge icon is displayed on the touch screen during charging from a low battery state to make sure the battery is charging the ventilator.
  • Observe any alarms from the Life2000 Ventilator System.
  • Contact Baxter Acute Care Customer Service Support for assistance with any alarms.
  • Review the system’s Quick Reference Guide for more details about the approximate ventilator battery charge, approximate time remaining, and associated alarms.

Device Usage

The Life2000 Ventilator System provides continuous or intermittent breathing 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. It can also deliver assist/control ventilation. It is used in both home and health care settings.