Patients can continue to use the system if they follow daily checks and preventive maintenance requirements. Credit: Parentingupstream / Pixabay.

An urgent medical device correction has been issued by healthcare company Baxter International for its Life2000 Ventilation System.

The company’s decision comes as a result of the potential for patient oxygen desaturation (low blood oxygen) events, which can take place in certain conditions when the Life2000 system is linked with a third-party oxygen concentrator.

Related Company Profiles

View all

The Life2000 system is manufactured by Hillrom, which was taken over by Baxter in 2021.

The latest correction is said to be applicable to all Life2000 Ventilation Systems that are used with an oxygen concentrator, including the Life2000 Ventilator Packaged (BT-20-0002), Life2000 Ventilator Packaged A (BT-20-0002A) and Life2000 System AC Package (BT200007).

Other systems that come under the correction are the Breathe Life2000 Ventilator PA (BT-20-0007), Life2000 System HC Package (BT200011), Breathe Technology Life2000 VE (BT-20-0011) and Life2000 Ventilator V6.X (MS-01-0118).

See Also:

Patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements according to an urgent medical device correction issued in January.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

These measures will help the system deliver better oxygen when it is used with a third-party oxygen concentrator, according to the FDA.

Baxter is continuing to monitor and evaluate reports received as well as study improvement opportunities.

The company will also issue a follow-up letter to patients to communicate further details on the actions that are being taken to address the issue.

Baxter currently supplies the Life2000 system in the US.

Low oxygen saturation can result in symptoms such as shortness of breath, confusion, rapid heart rate and bluish skin.

Oxygen desaturation incidents can be caused by hoses that are kinked or have excessive moisture; modified, extended, loose or disconnected tubing; and oxygen litre flow below the prescribed level from the concentrator.