Life2000 Ventilators Have a Potentially Deadly, Known Defect

Ventilators are supposed to help patients by increasing their oxygen intake, but Life2000 ventilators can do the exact opposite. Harris Lowry Manton LLP is representing clients who suffered harm from oxygen desaturation caused by defective Life2000 ventilators. These dangerous medical devices can cause fatalities, and we urge you to see medical advice immediately if you are using one of these systems. Then, call our lawyers in Atlanta or Savannah to learn more about your options.

What is the Life2000 Ventilation System?

The Life2000 Ventilation System is a modular ventilation system that is designed to “promote mobility and ambulation” for people with respiratory conditions such as chronic obstructive pulmonary disease (COPD).

It is manufactured by Hillrom, which was purchased by Baxter International Inc.

How does the Life2000 Ventilation System work?

The Life2000 is advertised as a “non-invasive” ventilator. The device has three main components:

1. The ventilator itself, which is a 1lb, rechargeable device designed to be worn on a belt.
2. The compressor, which “serves as the pressure source” for the ventilator.
3. The Breathe Pillows Entrainment Interface, which is the company’s name for the cannula and tubing that is attached to the ventilator.

The system works through a series of sensors, and by providing patients supplemental oxygen in conjunction with “ambient” air (AKA, the air all around us). Essentially, as a patient breathes in, the pressure is detected within the interface, and that information is relayed to the ventilator. The ventilator then determines how much supplemental oxygen to provide from a canister or concentrator, so that the patient receives the right amount of oxygen.

Oxygen tanks vs. oxygen concentrators

Oxygen tanks use compressed or liquid oxygen, and they are what most people think of when they think of supplemental oxygen. They need to be periodically refilled.

Oxygen concentrators pull oxygen from the air. They can be stationary or portable.

An oxygen concentrator is not included in the Life2002 Ventilation System.

Why is the danger associated with the Life2000 Ventilation System?

The Food and Drug Administration (FDA) reported that on January 25, 2023, Baxter issued an “Urgent Medical Device Correction notice to its healthcare providers, wholesalers, distributor/reseller, and durable medical equipment providers” about the potential for “patient desaturation events” associated with the Life2000 ventilator. It issued a second Correction on March 9, 2023, citing the same exact issue.

“Patient desaturation events” refer to oxygen levels. The Correction, in plain language, was a warning that under certain circumstances, the Life2000 Ventilation System could actually reduce the level of oxygen its users received “when the Life2000 system is connected with a third-party oxygen concentrator.” Because the people using this system are suffering from serious medical conditions like COPD, these “events” are potentially life-threatening.

Baxter International’s website lists the following causes of concern for its Life2000 Ventilation System:

• Kinked hoses;
• Excessive moisture in the hoses;
• Modified tubing, including tubing extenders;
• Disconnected tubing;
• “Oxygen liter flow” that falls below prescribed levels; and/or
• Poor maintenance of the system and/or oxygen concentrator.

Again, no oxygen concentrator is provided as part of Baxter International’s Life2000 Ventilation System which means every oxygen concentrator is, by necessity, a third-party concentrator. As such, every single person who uses this particular system is at risk of injury or even death if they are prescribed a concentrator as part of their oxygen therapy.

What are the signs of low oxygen?

The most common sign of low oxygen is shortness of breath. Per the Other signs can include:

• Headaches;
• Rapid heartbeat;
• Coughing;
• Wheezing;
• Blue tint to skin, lips, and fingernails; and
• Confusion.

What happens if your oxygen levels are too low?

Low oxygen levels can result in hypoxemia, which is when your blood does not get enough oxygen. It can also lead to hypoxia, which occurs when your tissues and organs do not have enough oxygen. Left untreated, either condition can potentially lead to organ damage or death.

Which Life2000 systems are affected?

According to the FDA, every Lifes2000 system has this defect. The following products are also listed on Baxter’s Correction notice:

• Life2000 Ventilator Packaged (BT-20-0002);
• Life2000 Ventilator Packaged A (BT-20-0002A);
• Life2000 System AC Package (BT200007);
• 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).

What should I do if I experience low oxygen levels/oxygen desaturation?

If you are using a Life2000 Ventilation System along with a prescribed oxygen concentrator, and you experience the symptoms of low oxygen, check the connections and tubing to see if adjustments can increase your oxygen levels. If you can connect the tubing directly to the concentrator, consider doing so to raise your levels. Then, immediately contact your doctor to see what you should do next.

If you or your loved one is experiencing a medical emergency, call 9-1-1 immediately.

What should I do if I use a Life2000 Ventilation System?

If you were prescribed the Life2000 Ventilation System and experienced an adverse event, there are several steps you should take:

1. Contact your doctor to request an appointment and discuss other options for your oxygen therapy needs.
2. Report the event to the FDA MedWatch Serious Injury Reporting Program, which tracks injured caused by dangerous medical products and devices. You can request a paper copy to mail by calling 800-332-1088 or downloading this form.
3. Contact Harris Lowry Manton LLP in Atlanta or Savannah to learn more about your legal options.

Can your Georgia medical product liability lawyers help?

Harris Lowry Manton LLP has decades of experience representing clients who have been injured or harmed by defective devices. We are the only Georgia law firm to secure #1 verdicts in product liability and medical malpractice, along with five other areas of injury law, over the past 15 years. We have secured millions of dollars on behalf of clients who were injured or lost loved ones because of defective devices.

Our product liability attorneys are your advocates. We will fight to obtain the compensation you need for damages such as:

• Medical costs and expenses, both current and expected
• Lost wages and income, including benefits and a loss of earning potential
• Pain and suffering, both physical and emotional
• Other associated costs for transportation, home services, and more
• Punitive damages (if applicable)

If your loved one died because of a defective Life2000 Ventilation System, we can help you file a wrongful death lawsuit. Our attorneys in Savannah and Atlanta serve all of Georgia and can travel to you if you cannot come to us. We can also schedule a phone or video consultation.

Baxter International’s Life2000 Ventilation Systems have a known and unavoidable defect, yet they are still marketing these systems to people with potentially life-threatening medical conditions. Baxter has not recalled their system, nor truly accepted responsibility for the harm they cause. Harris Lowry Manton LLP is here to help you hold them accountable. Contact our medical product liability lawyers in Atlanta or Savannah by calling us or filling out our contact form. Proudly serving all of Georgia.