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Philips CPAP Devices, BiPAP Machines and Ventilators Recalled Over Safety Concerns

What You Need to Know About the Philips Respironics CPAP Ventilator Recall

Earlier this summer, the United States Food and Drug Administration announced a mass recall of Philips Respironics CPAP devices, BiPAP machines, and ventilators.¹

Investigation into these products is ongoing.

But the CPAP devices contain small foam parts used to limit machine noise and vibrations. Composed of polyurethane, the parts are known as sound abatements.

These foam parts can degrade and break down into microscopic particles.²

The tiny fragments of polyurethane foam can enter the machines’ air hoses.

The foam particles may be further degraded by heat and humidity environments. The polyurethane foam can also break down from being cleaned with unauthorized substances like ozone.

Patients can inhale or swallow the foam particles.

The degraded particles of polyurethane can be microscopic.

A patient might be unaware of inhaling them.

Patients can also inhale or swallow black debris or chemicals released by the foam.

Polyurethane and chemicals released by the CPAP ventilators with degraded foam may be toxic or even carcinogenic.

A carcinogen is a substance known to cause cancer.

According to the FDA, inhaling the polyester-based polyurethane can lead to a range of health problems.

Specifically, these contaminants can negatively affect a patient’s:

Symptoms that may indicate health problems caused by Phillips CPAP devices:

The FDA report lists a number of health concerns raised by the particles, chemicals and polyurethane fragments released by some Phillips CPAP devices. Symptoms include:

What Are the Recalled Philips Respironics’ Products Used For?

Philips Respironics’ recalled BiPAP and CPAP devices are primarily used to treat sleep apnea.

What is sleep apnea?

Sleep apnea is a sleep disorder that can have potentially serious effects.

People with sleep apnea suddenly stop breathing during their nightly sleep.

Two symptoms of sleep apnea are:

• Loud snoring
• Feeling tired after a full night’s sleep

Sleep Apnea affects millions of Americans, especially men.

Researchers estimate that 25% of men suffer from sleep apnea, compared to nearly 10% of women.

There are two main types of sleep apnea:

People who have sleep apnea have difficulty breathing when asleep.

Some sleep apnea patients may stop breathing hundreds of times over the course of a single night.

Left untreated, sleep apnea can cause numerous health problems,⁷ including:

People with sleep apnea are sometimes prescribed treatment with CPAP and BiPAP machines.

Philips CPAP and BiPAP machines are both devices used for what is known as  Both Positive Airway Pressure therapy. Positive Airway Pressure therapy is also called PAP.

In PAP therapy, a mechanical device—like a CPAP or BiPAP machine—gently forces air through a patient’s mouth and nose, providing just enough pressure to prevent airway obstruction and force the body into breathing normally.

The main difference between CPAP and BiPAP machines is that:

Which Philips Devices Are Being Recalled By The FDA?

NOTE: The F.D.A. recall does not affect every Philips-manufactured device.

According to Reuters, an estimated 80% of the recalled products are CPAP machines, while the remaining 20% are ventilators.

The recalled CPAP and BiPAP models include the following continuous ventilator-minimum ventilatory support model:

• E30

… and the following continuous ventilator-non-life supporting models:

… and the following noncontinuous ventilator models:

You can find the full list of affected BiPAP devices, CPAP machines, and ventilators on the F.D.A.’s medical device recall page.

What to Look for If You Have Used a Recalled Philips Device

If you have used one of Philips’ recalled devices, you should consider whether you have experienced side-effects such as:

Philips’ own post-recall reports suggest that some devices are more vulnerable to polyester-based polyurethane contamination than others:

Since CPAP devices are typically replaced every five years, you may have been exposed to polyester-based polyurethane-containing CPAP or BiPAP machines in the past, even if you no longer use an affected Philips product.

If you cannot remember which brand of CPAP or BiPAP machine you used prior to your current model, you should ask your health care provider to help you obtain your medical records.

A Word of Caution: Be Careful Whom You Speak With

The Department of Veterans Affairs has asked veterans with recalled CPAP and BiPAP machines to register their devices on the Philips website. Philips Respironics has pledged to replace all recalled machines once replacements become available.

However, anyone who has used faulty CPAP or BiPAP devices may want to avoid engaging with Philips Respironics.

Anyone seeking to replace a recalled Philips device must fill out a questionnaire.

This questionnaire may request detailed information on:

• Your health history
• Your medical records and diagnoses
• Your device cleaning habits and techniques

The information you give to the Philips company if you replace your product can be used against you if you ever take legal action for injuries caused by Philips’ defective products.

Even if you have pre-existing lung problems or cardiovascular disease, you could still be entitled to funds from an eventual settlement.

Have You Been Hurt By a Philips Respironics CPAP or BiPAP Machine?

Since Philips and the F.D.A. are continuing to investigate the long-term effects of polyester-based polyurethane inhalation, CPAP and BiPAP users may feel frightened about what the future holds.

But there are warriors for the wounded already preparing to challenge Philips Respironics for injuries caused by any negligent manufacture of patently unsafe products.

If you or a loved one has suffered side-effects that may be related to a recalled Philips CPAP or BiPAP machine, you may have means for recourse. When a person or company hurts somebody else through carelessness, the injured person can recover compensation in court.

The law provides recovery for different types of damages:

• Past, future, and anticipated medical expenses resulting from a faulty product
• Lost wages, or reduced income for injuries that kept someone away from work
• Mental pain and suffering caused by physical injury, medical diagnoses, and emotional trauma
• Wrongful death

Even people with pre-existing lung problems or cardiovascular disease may be entitled to funds from an eventual legal settlement for the recalled Phillips CPAP and BiPAP ventilators.

A Texas Personal Injury Law Firm That Knows What You’re Up Against

Call, text or email us for a free consultation, with no obligation. Speak to a Texas personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.

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^{[1] Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, U.S. Food and Drug Administration (FDA), (Date Issued: June 30, 2021).}

^{[2] Medical Device Recall Notification – Philips Respironics Sleep and Respiratory Care devices, Phillips.com (Issued June 14, 2021).}

^{[3] Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, U.S. Food and Drug Administration (FDA), (Date Issued: June 30, 2021).}

^{[4] Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, U.S. Food and Drug Administration (FDA), (Date Issued: June 30, 2021).}

^{[5] Obstructive sleep apnea: Overview, InformedHealth.org [Internet]. Cologne, Germany: Institute for Quality and Efficiency in Health Care (IQWiG); 2006-. 2011 Jul 22 [Updated 2019 Jan 2].}

^{[6] Central sleep apnea: Pathophysiology and treatment, Eckert, Danny J et al., Chest vol. 131,2 (2007).}

^{[7] Recognition and Consequences of Obstructive Sleep Apnea Hypopnea Syndrome, Susan Redline, MD, MPH Kingman and P.Strohl, MD}

^{[8] Troubleshoot It: CPAP and BiPAP Machines: Similar Devices with Key Differences in Functionality, Becky Crossley Biomedical Instrument Technology (2020).}

^{[9] Rising prevalence of sleep apnea in U.S. threatens public health, American Academy of Sleep Medicine (Sept. 29, 2014).}

^{[10] Healthcare Startup Grows 2,805 Percent In 7 Years With CPAP Sanitizer, Daniel D’Ambrosio, Forbes.com (Dec 21, 2018).}

^{[11] VHA National Center for Patient Safety, Department of Veterans Affairs (April 26, 2021).}