Philips CPAP, BiPAP, and Ventilator Recall Due to Health Risks
In June of 2021, Philips (which you may also see referred to as Royal Philips or Philips Respironics) recalled several CPAP, BiPAP, and ventilator devices. The Food and Drug Administration (FDA) issued a Class 1 recall – the most severe class.
The recall results from a severe health risk linked to the sound-abatement foam used to make the machines quieter. The foam, a polyurethane product, can break down and emit toxic gases and introduce particles into the air it delivers. These particles may be inhaled or swallowed and can lead to dire health consequences.
Within approximately one month of the recall announcement (as of July 23, 2021), AARP reported that the FDA had received more than 1,200 complaints and more than 100 reports of injuries.
If you or someone you love is a user of an affected device, contact your healthcare provider immediately. If you have suffered a harmful side effect from using an affected CPAP or BiPAP machine such as chronic respiratory illness, asthma, or lung cancer, or have experienced a significant worsening of your condition after using an affected ventilator, contact a defective product attorney to protect your rights. You can call us anytime at 1-866-900-7078.
What Are the Recalled Philips Devices Used For?
All recalled devices (see below) are used to aid in breathing, with 80% of them used to treat sleep apnea. As such, all of the devices have direct access to the body through the lungs.
Who Could Be Affected by Recalled Philips CPAP and BiPAP Machines?
CPAP and BiPAP machines help people who suffer from obstructive sleep apnea, a medical condition affecting millions of Americans that can cause them to stop breathing while they sleep. The devices work by creating positive airway pressure (PAP) to keep the airway open during sleep.
CPAP machines pressurize air to provide continuous positive airway pressure, ensuring that the user’s airway remains open during sleep.
BiPAP machines work just like CPAP machines, but they have two pressure settings instead of just one. While a CPAP machine provides one constant pressure, a BiPAP machine has an “inhalation positive airway pressure” (IPAP) and a lower “exhalation positive airway pressure” (EPAP) setting.
The recall means that people who rely on their CPAP and BiPAP machines to keep them breathing as they sleep can be caught in a no-win situation. For many, their physician may deduce that the risk of discontinuing CPAP or BiPAP use is too risky and recommend that they continue to use these dangerous machines until a replacement or substitute is available.
Who Could Be Affected by Recalled Philips Ventilators?
Ventilators assist the lungs by forcing air into a patient whose lungs are not working well enough or whose condition limits their breathing. Many users at risk from the devices are already battling a health condition that may reduce their ability to cope with the new danger. Examples may include the elderly, people suffering from various lung or respiratory illnesses, and those on oxygen therapy.
What Products Are Affected by the Philips CPAP Recall?
Philips recalled millions of devices containing the faulty sound-abatement foam due to the machines’ health risks to users. The list includes several lines of non-life supporting ventilators and all of its CPAP and BiPAP machines manufactured before April 26, 2021. In the US, the following devices were recalled:
- E30 continuous ventilators
- DreamStation non-life supporting continuous ventilators (models ASV, ST, and AVAPS)
- SystemOne ASV4 continuous ventilators
- C Series continuous ventilators (models ASV, S/T, and AVAPS)
- OmniLab Advanced Plus in-lab titration devices
- SystemOne Q series non-continuous ventilators
- DreamStation CPAP, Auto CPAP, and BiPAP ventilators
- DreamStation Go CPAP and APAP non-continuous ventilators
- Dorma 400 and 500 CPAP non-continuous ventilators
- REMstar SE Auto CPAP non-continuous ventilators
- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, and LifeVent continuous ventilators
- A-Series BiPAP V30 Auto and Hybrid A30 continuous ventilators
It is important to note that the recalled devices date back as far as 2009, and some users may have been at risk for much longer than others. Between three and four million machines are affected globally.
If you use or depend on any of the affected devices, the recall means uncertainty about your present medical conditions and possible future harm from using the faulty devices.
What Should I Do if My Philips CPAP Is Recalled?
- If the Philips CPAP, BiPAP, or ventilator you use is on the recall list, consult your healthcare provider. The action you should take depends on your condition, circumstances, and the recommendation of your healthcare provider. Possible actions include:
- Continuing to use the device until a replacement or substitute is available. Your healthcare provider may determine that the benefits of using the device outweigh the risks in your particular case.
- Discontinuing use of the device. If your condition is favorable to doing so, your physician may advise you to stop using your device. Do not discontinue use unless advised by your healthcare provider.
- Using a similar, non-recalled device. Though the availability of replacements has been problematic, you may be told to use an alternative machine.
- Switching treatments. For sleep apnea sufferers, alternative therapies may be considered, including positional therapy or oral appliances. You may also be offered other long-term therapies, including reduced alcohol intake, weight loss regimens, quitting smoking, or even surgical remedies.
- Monitor your health. You may be entitled to compensation if you’ve used an affected device for more than a year and suffer from new or worsening chronic respiratory illness, asthma, or lung cancer.
Why Exactly Are Philips CPAP Machines Being Recalled?
The recalled devices use polyester-based polyurethane (PE-PUR) foam for sound abatement. When the foam breaks down, it can emit harmful gases and produce harmful particles for users to inhale or swallow. Given that some devices may have been in use since 2009 and that risk may increase as the device’s foam degrades, the threat to some users may be incredibly high.
While the foam enables devices to run more quietly, polyester-based polyurethane foam is well known.
Polyurethane exists in some form or another all around us. It’s in everything from mattresses and office chairs to spray-in insulation. In its foam form, as in many others, polyurethane is highly flammable – so much so that products made from it must have fire retardants added (which can themselves be harmful). Polyurethane spray foam can also emit toxic substances, like isocyanates, though it is unclear what specific formulation the recalled devices use.
What Are the Health Problems Caused by Recalled Philips CPAP and Other Devices?
Philips has identified two types of risks to users: exposure to degraded foam and exposure to chemical emissions. According to the company:
Exposure to Chemical Emissions: “The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.”
Exposure to Degraded Foam: “The potential risks of degraded foam exposure include: irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g., kidneys and liver) and toxic, carcinogenic effects. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection.”
Meanwhile, the FDA warning doesn’t mince words. The administration states that the risks could be “life-threatening, cause permanent impairment, and require medical intervention.” And the list is alarming:
- Airway inflammation, which poses an extreme risk to people with lung disease or reduced breathing capacity
- Respiratory tract irritation
- Various cancers, especially in the lungs
- Hypersensitivity reactions
- Organ damage, including liver or kidney problems
If you’ve used any of these devices for a year or more and suffered any of the health problems listed above, you may be entitled to compensation. Call us at 1-866-900-7078 right now, or contact us online.
Am I Eligible to File a Lawsuit Against Philips or Receive a Settlement?
If you’ve used the device for more than one year and developed any of the problems associated with the recall, talk to your physician. Your condition may be the result of the faulty Philips device, and you may be eligible to file a lawsuit and seek compensation.
Remember: the risk increases as the foam in the devices degrades. Contact an experienced defective product attorney to protect your rights and fight for any compensation you may deserve.
How Can Attorneys Accepting Philips CPAP Cases Help Me?
When you suffer an injury due to a defective product, the consequences should not be yours to bear. The people at-fault for the defect should compensate you for the harms and losses that product caused you. In most cases, they won’t simply give you compensation. You have to fight for it.
That’s where an experienced defective product attorney comes in. We try to hold companies accountable for the harm they’ve done. Some of the ways we use can include:
- Investigating the products, manufacturing processes, and materials used in production
- Seeking information, including information that may not be obtainable without legal justification
- Engaging experts as necessary, including doctors, scientists, chemists, and engineers
Defective products can be the result of carelessness on the part of manufacturers. Some may try to cut costs or cut corners to get a product to market. Perhaps the products are not sufficiently tested or contain some design flaw that takes years to emerge. In the case of the recalled Philips products, polyester-based polyurethane foam is not a new substance. It’s been around for many years, and its attributes and limitations are well known.
What Kinds of Compensation Could I Get From a Philips CPAP Lawsuit?
You can seek compensation for any harms and losses you suffered. How much you seek depends on the circumstances and your unique situation, but they can include:
- Medical costs (present and future)
- Lost wages
- Loss of companionship
- Pain and suffering
Most fail to consider the long-term effects of their conditions and the cost of future medical care. Some of the conditions caused by the faulty Philips CPAP, BiPAP, and ventilator machines may affect you for the rest of your life.
Call the Defective Product Attorneys at the Law Offices of James Scott Farrin
If you’ve been using your Philips CPAP, BiPAP, or ventilator for more than a year and suffered any of the following medical conditions, contact us immediately:
- Chronic respiratory illness
- Lung Cancer
Since 1997, we’ve helped more than 50,000 clients recover more than $1.2 billion in total compensation, not including a historic class action case where we helped thousands of Black farmers win more than $1.25 billion in compensation from the U.S. government.1
And there is no out-of-pocket cost to you to pursue compensation for your injury. We work on a contingency fee basis, meaning we only collect an attorney’s fee if we collect for you.2
You may be entitled to compensation for your present and future medical costs, lost wages, pain and suffering, and more. Call us right now at 1-866-900-7078, or get in touch with us online for a free case evaluation.Text Us
The Law Offices of James Scott Farrin consults with a national network of attorneys on product liability, defective drugs, and defective products cases in an attempt to provide the best representation we can for our clients. Depending on the details of your case, our firm will likely refer your matter to another law firm with which we associate. We will only do this if we believe it is in your best interests and if you agree.