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Ventilator Correction: Baxter Healthcare Updates Use Instructions for Life2000 Ventilation System Due to Risk of No Low Gas Pressure Alarm

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. 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 without following the updated instructions.  

Affected Product

  • Product Name: Life2000 Ventilators 
  • Unique Device Identifier (UDI)/Model: 00887761978089/ MS-01-0118 or 0081541002053/ MS-01-01187
  • Lot/Serial Numbers: All Life2000 Ventilators with software version 06.08.00.00   

What to Do  

  • 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. 

On September 12,2024, Baxter Healthcare sent all affected customers an Urgent Medical Device Correction letter recommending the following actions: 

  • Ensure the Life2000 ventilator is connected to a pressure gas source (Life2000 compressor, oxygen cylinder, or wall source) before it is turned on. 
    • Refer to setup instructions in the Quick Reference Guide, pages 11 to 13.
  • Review the Quick Reference Guide, Instructions for Use, and other information 
  • Respond to the notification based on the instructions included in the letter based on the type of user (see for home care users/patients and for healthcare providers/patients below).
  • If product was received from a distributor or wholesaler, respond according to that supplier’s instructions. Response through the Baxter customer portal is not available. 

For home care users/patients 

  • Acknowledge receipt of the notification as shown on the Home Patient Reply Form Instruction Sheet included with the letter. 
    • Prompt acknowledgement will prevent repeat notifications, including a phone call from On Process Technology on behalf of Baxter. 
  • If product was received from a distributor or wholesaler, respond according to that supplier’s instructions. Response through the Baxter customer portal is not available. 

For healthcare providers and patients 

  • Acknowledge receipt of the notification through the Baxter customer portal https://BaxterFieldActionCustomerPortal.onprocess.com. 
    • Log in to the portal using the account number listed in the reply form instruction sheet included with the letter. 
    • Prompt acknowledgement will prevent repeat notices, including a phone call from OnProcess Technology on behalf of Baxter to confirm receipt.

Reason for Updates to Use Instructions  

Baxter Healthcare is updating use instructions for the Life2000 ventilator after identifying that this 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. 

The use of affected product may cause 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.  

Device Use 

The Life2000 Ventilation System is intended 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. It can also deliver assist/control ventilation. It is used in both home and health care settings.

Contact Information  

Customers in the U.S. with questions about this recall should contact Advanced Respiratory, Inc. Acute Care customer service at the following phone numbers:

  • Health care providers/customers: 800-426-4224, option 2.
  • Home care/patients: Home Care Customer Service 800-426-4224, option 3. 

Additional FDA Resources (listed in order of most to least recent):  

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

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