Philips Recalls Millions of CPAP, Ventilator Machines Over Health Risks
Philips recalls millions of CPAP, ventilator machines over potential health risks
In November 2021, the U.S. Food and Drug Administration (FDA) released an update on their June 2021 recalled device notice for various bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices manufactured by Philips. These breathing devices contain polyester-based polyurethane (PE-PUR) sound abatement foam, which can degrade over time and cause users to develop health issues, including cancer.
If you or a loved one used one of Philips’ Respironics Sleep & Respiratory Care or other recalled CPAP machines and developed an injury or illness, you may qualify to file a claim or lawsuit to pursue compensation. A personal injury lawyer can review your case and continue to follow the FDA’s updates to see where your case stands.
The FDA’s recall notification issues advice for patients and customers
Philips initially sent out a recall on its medical devices on June 14, 2021, warning consumers to cease using specific models of sleep apnea machines the company produced. The device manufacturer stated in the recall notice that the company wanted to initiate voluntary recall notification to “ensure patient safety” in accordance with regulatory agencies like the FDA.
The FDA recommends consulting your physician to assess safety risks
In the FDA’s November update to the June 2021 recall notice, the administration recommended that patients and consumers should follow the original instructions of the Class I recall. These instructions included:
- Cease use of the recalled Philips-brand sleep apnea machine immediately.
- Consult your physician to determine whether you can continue use or should use a different breathing device.
- Get a physical exam and other necessary diagnostic tests performed if you experience any side effects from using your sleep apnea device.
Some patients may still be able to use their CPAP, BiPAP, or ventilator device if the health risks of sleep apnea outweigh the health risks associated with using the recalled devices. Philips also offers a repair and replacement program for those who purchased one of the qualifying devices.
Recalled Philips BiPAP, CPAP, and ventilator medical devices
Philips has recalled the following BiPAP, CPAP, and ventilator breathing devices:
- A Series BiPAP A30 and A40
- A Series BiPAP Hybrid A30
- A Series BiPAP V30 Auto
- DreamStation ASV
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation ST, AVAPS
- DreamStation GO CPAP, APAP
- SystemOne ASV4
- SystemOne (Q-Series)
- C Series ASV
- C Series S/T and AVAPS
- Garbin Plus, Aeries, LifeVent
- OmniLab Advanced Plus (In-Lab Titration Device)
- Dorma 400 CPAP and 500 CPAP
- E30 (Emergency Use Authorization)
- REMStar SE Auto CPAP
- Trilogy 100 and 200
These devices were manufactured prior to April 26, 2021. The recall is based on information collected in Philips’ first-quarter company report. If you are currently using any of these devices, you should consult your physician to determine if it is still safe for you to continue use or if there are other options available to treat your sleep apnea.
Possible health risks associated with using the recalled Philips medical devices
On June 30, 2021, the FDA issued a health notice following the Class I recall on Philips Respironics, noting significant health risks associated with the recalled devices.
As mentioned, these devices use polyester-based polyurethane (PE-PUR) sound abatement foam to lower noise from the sleep apnea machine. However, foam degradation can occur over time, releasing black debris from the foam into the machine tubing. Should patients inhale or swallow the black debris, they can suffer several side effects. In addition, these particles are also carcinogenic, posing a cancer risk for users.
Symptoms of exposure to Philips CPAP machine foam particles
If you were exposed to pieces of foam in your CPAP, BiPAP, or ventilator machine, you might experience the following side effects:
- Irritation in your nose, throat, and respiratory tract
- Irritation in your eyes on your skin
Some patients using the affected devices will experience signs of cancer in their organs, such as the liver or kidneys. This is because the foam contains volatile organic compounds (VOCs), which can release into the tube airways and get inhaled by patients. The FDA also notes that people who live in hot and humid climates or use ozone cleaners may put their devices more at risk for foam degradation.
Potential health risks of inhaling PE-PUR foam chemical emissions
Potential health risks of inhaling PE-PUR foam chemical emissions include:
- Irritation in areas that have direct contact with the machine’s tubing (e.g., eyes, skin, nose, mouth)
- Allergic reaction
- Immune system reaction, including inflammation
- Headaches and migraines
- Nausea or vomiting
- Side effects related to cancer and toxin poisoning
- Dyspnea, or difficulty breathing
- Chest pain
If you are experiencing any of these symptoms, consult with your physician immediately.
Philips created a repair and replacement program for patients
Philips has developed a repair and replacement program for patients using the affected medical devices listed in the recall notice. With this program, Philips agrees to:
- Replace machines in the first-generation DreamStation product families with DreamStation 2 models or newer
- Send out the replacement device upon receipt of the original recalled device by the consumer
- Manufacture CPAP, BiPAP, and ventilator machines that do not rely on sound abatement foam but safer alternatives
- Increase production of DreamStation 2 products in the United States and Europe
The repair and replacement program launched in June 2021 and is still in place until further notice. Consumers do not have to pay for the replacement device as part of the recall.
Additional information about sleep apnea
Philips is one of the main manufacturers of sleep apnea machines in the United States and Europe, making it understandable why the recall would affect many patients’ lives and health. Philips Chief Executive Frans van Houten expressed sentiments in The Wall Street Journal, saying, “We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety.”
To understand how these machines may affect patients, it may be good to learn more about sleep apnea and how this sleeping disorder affects patients’ lives in general.
Risk factors that can lead to sleep apnea
Sleep apnea is a sleeping disorder that affects an individuals’ breathing. People with sleep apnea may unexpectedly stop breathing throughout the night, which can be life-threatening if they do not send neural signals to continue breathing again. Some immediate signs to look for is loud snoring and feeling tired in the morning despite having a full night of rest.
Certain factors can increase a person’s risk for developing sleep apnea, such as:
- Being overweight: Fatty tissue around the throat area or breathing airways can obstruct breathing at night, especially in certain lying positions (e.g., lying on your back).
- Being male and/or older: According to Mayo Clinic, men are two to three times more likely to develop sleep apnea in their lives than women. However, men and women who have reached retirement age are more likely to develop sleep apnea than younger people.
- Family and medical history: If you have a history of sleep apnea in your family, you are likely to develop the sleeping disorder. Alternatively, other medical conditions can increase your risk of sleep apnea, such as high blood pressure, type II diabetes, congestive heart failure, polycystic ovary syndrome (PCOS), hormonal disorders, and chronic lung diseases.
If you feel tired at night and exhibit any of these risk factors, you may want to consult with your physician about sleep apnea if you need to treat your condition.
Obstructive sleep apnea
Obstructive sleep apnea occurs when the muscles in an individual’s throat, such as the tongue and soft palate, are too relaxed that they obstruct breathing. When these muscles relax, they can lay flat against the throat airway, which then prevents a person from being able to breathe.
Other risk factors that can lead to obstructive sleep apnea in addition to those already listed include:
- Anatomical structure: People with certain anatomy may be prone to developing obstructive sleep apnea, such as individuals who have thick necks or naturally narrowed airways. People who still have their tonsils or adenoids can also have narrowed airways for breathing.
- Nasal congestion: If you have allergies or are prone to nasal congestion, these conditions can obstruct your breathing at night, which can lead to sleep apnea.
- Substance use: People who smoke, drink alcohol, or use sedatives or tranquilizers are more likely to develop obstructive sleep apnea. Smoking inflames the upper airway and makes individuals prone to fluid retention, where alcohol and certain drugs may relax the throat muscles too much during sleep.
Central sleep apnea
Central sleep apnea occurs because of neurological dysfunction. An individual’s brain does not send enough or proper signals to maintain their breathing throughout the night. This means a person will momentarily stop breathing throughout the night because their throat and respiratory muscles are not being directed to take air in.
Other risk factors that can lead to central sleep apnea besides those already listed include:
- Heart disorders: If you have been diagnosed with congestive heart failure or another heart condition, such as coronary heart disease, then you have a higher risk of central sleep apnea in your life.
- Stroke: People who have had strokes or are at risk of having a stroke may develop central sleep apnea as a side effect due to the neurological changes stroke can make in the body.
- Narcotic pain medications: People who use long-acting opioid medications may increase their risk of central sleep apnea.
If you are experiencing health issues, you should see a doctor
Whether you exhibit signs of obstructive or central sleep apnea, this is a serious health condition to monitor, as the consequences can be high for those who do not regularly treat it. For example, if you continue to sleep with untreated sleep apnea, you can be putting yourself at risk of:
- Developing other serious health conditions: Sleep apnea can lead to other health issues such as high blood pressure, heart disease, type II diabetes, metabolic syndrome, and liver problems.
- Feeling tired throughout the day: If you continuously stop breathing throughout the night, you are not getting full rest and will feel fatigued. Sleep deprivation can affect your autoimmune system, mental health, work productivity, and overall wellness.
- Complications with medications: People with obstructive sleep apnea may not be able to take certain medications because of their breathing obstruction. This can particularly affect medications necessary before and after surgery, as individuals may not be able to retain medicines while sedated or lying down.
Individuals with sleeping partners may also risk jeopardizing their relationship or partner’s health. For example, partners may be unable to sleep throughout the night because of the individual’s snoring.
You can speak with your physician about your sleep apnea machine
If you are using a Philips BiPAP, CPAP, or ventilator machine that has been recalled, you should speak with your primary care physician right away to see how you can continue to treat your sleep apnea without putting your health at risk. If you exhibit symptoms of PE-PUR foam exposure, you can also alert your physician so that they can conduct proper tests.
Once you get medical documentation of your condition, you may want to consider filing a claim or lawsuit about any injuries or illnesses caused by your Philips sleep apnea machine. A personal injury lawyer can guide you on the legal process and represent your case.
Get a free consultation about your defective Philips CPAP machine today
If you or a loved one used a recalled Philips CPAP machine and suffered health consequences because of it, you may qualify to pursue compensation for your injury, illness, and/or other damages. We can direct you to a personal injury lawyer who handles defective product cases in your area and can represent you.
Fill out our contact form today for help with your case or to learn more about bringing the manufacturer to account.