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Philips CPAP Machine

In the United States alone, there are more than 8 million people who use CPAP machines. These people rely on this medical device to treat their sleep apnea in order to sleep through the night without stopping breathing.

Philips is one of the largest manufacturers of CPAP machines in the world, with the second-largest market share in the CPAP machine market. This means that hundreds of thousands of people may have used Philips’ CPAP machines. That’s a lot of people who could be affected by Philips’ recall of certain CPAP machines.

Not only could they be negatively impacted by the defects in those CPAP machines but they may also have to wait for replacement parts to come in, which means that many people may not be able to use their CPAP machines to treat their sleep apnea anymore. Some people may be waiting for years for their replacement parts.

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What Is a Philips CPAP Machine?

A CPAP machine is a medical device that doctors prescribe to patients who have sleep apnea. There are different types of sleep apnea, but all of them interrupt your breathing while you sleep. A CPAP machine is designed to help you breathe so that you can sleep through the night since sleep apnea interrupts sleep every time your breathing is interrupted. 

Philips is the second-largest manufacturer of CPAP machines in the world, with 30% of the market share in the CPAP industry.

What Does a CPAP Machine Do?

A CPAP machine is a breathing machine that sends a flow of air through your airways via a mask that covers your nose and mouth. The air is pressurized and comes through in a steady stream to keep your airways open while you sleep. This prevents any obstruction from interrupting your breathing.

How Does a CPAP Machine Work?

A CPAP machine is made up of a compressor, a tube, and a mask. The compressor generates pressurized air, which is then sent through the tube and into the mask, which covers your mouth and nose. The air is pushed into your airways and from there to the lungs. Because of the way the pressurized air is pushed through your airways, it clears up any obstructions that could be interrupting your breathing. The flow of air is continual, which means that your breathing never pauses during sleep.

What Kind of CPAP Machines Are There?

All CPAP machines contain the same basic set of components:

  • Mask
  • Adjustable straps
  • Headgear frame
  • A tube connecting the compressor to the mask
  • A base unit containing the motor
  • Elbow joint pieces

The primary way in which CPAP machines differ from one another is in the type of mask that the units use. People who use CPAP machines to treat sleep apnea can choose from a few different mask types so that they can use the one that works best for them. There are three different types of CPAP machine masks:

  • Full mask
  • Nasal mask
  • Nasal pillow mask

The full mask covers both your nose and mouth while the nasal mask options cover only the nose. The nasal mask and nasal pillow mask differ in how they fit over the nose. The nasal mask covers the nose while the nasal pillow mask has two prongs that insert into the nostrils. Which one you choose depends on what is most comfortable for you. Some people prefer the smaller nasal masks because they find it difficult to sleep with a full mask on. People with a lot of nasal hair may find that a nasal pillow mask stays on better because of its prongs when a mask that covers the nose or face might not be able to fit snugly around the hair.

What Does a CPAP Machine Treat?

 A CPAP machine treats sleep apnea, which is a potentially very serious sleep disorder that involves the continual stopping and restarting of the breathing process. Sleep apnea can lead to a variety of different health problems if it isn’t treated, including diabetes, heart attack, and stroke. Doctors prescribe CPAP machines for patients because they help to treat sleep apnea and prevent breathing from getting interrupted during the night, which in turn helps to ensure a full night’s sleep.

What Is Sleep Apnea?

Sleep apnea is a sleep disorder in which breathing stops and starts while someone is sleeping. There are three types of sleep apnea:

  • Central sleep apnea
  • Obstructive sleep apnea
  • Complex sleep apnea syndrome

The symptoms of these different types of sleep apnea can overlap, which may make it difficult to know exactly which type of sleep apnea someone has. However, a CPAP machine can be used to treat all three types of sleep apnea.

What Is Central Sleep Apnea?

Central sleep apnea is a type of sleep apnea that occurs when your brain isn’t sending the right signals to the muscles in charge of controlling your breathing. It’s rarer than obstructive sleep apnea but has similar symptoms. Additionally, the outcome is the same in that breathing stops while you’re sleeping, which causes poor sleep due to partial or complete waking. Sometimes, central sleep apnea is caused by other health conditions, such as stroke or heart failure. Sleeping at a high altitude can also result in central sleep apnea.

What Complications Can Central Sleep Apnea Cause?

Central sleep apnea can cause fatigue and cardiovascular problems. This is because when you stop breathing during the night, your body at least partially wakes up, resulting in you not getting a good night’s sleep. Additionally, the reduction in the amount of oxygen your body takes in can negatively impact your cardiovascular system.

What Can Put You More at Risk for Central Sleep Apnea?

The risk factors that can increase your likelihood of developing central sleep apnea include the following:

  • Sex
  • Age
  • CPAP machine usage
  • High altitude
  • Use of opioids
  • Atrial fibrillation (irregular heartbeat)
  • Congestive heart failure
  • Stroke
  • Brain tumor
  • Structural brainstem lesion

What Can Cause Central Sleep Apnea?

Central sleep apnea can be caused by health conditions that impact the brainstem. The brainstem is what links your spinal cord and brain together and it controls bodily functions such as breathing and heart rate. There are different types of central sleep apnea and each one has a different cause.

What Is Drug-Induced Apnea?

Drug-induced apnea is a type of central sleep apnea that is caused by certain medications, including:

  • Codeine
  • Oxycodone
    • Oxycontin
    • Roxicodone
    • Etc.
  • Morphine
    • Kadian
    • MS Contin
    • Etc.

Taking these medications to treat another health condition can result in the development of central sleep apnea.

What Is Cheyne-Stokes Breathing?

Cheyne-Stokes breathing is a type of central sleep apnea that involves a gradual increase in airflow and breathing effort, followed by a gradual decrease. During its lowest flow of air, breathing can stop altogether, which is when central sleep apnea occurs. This health condition is typically caused by stroke or congestive heart failure.

What Is High-Altitude Periodic Breathing?

High altitude periodic breathing occurs when someone develops Cheyne-Stokes breathing while sleeping at a high altitude. This occurs because of the changes in how much oxygen you can intake while breathing.

What Is Treatment-Emergent Central Sleep Apnea?

Treatment-emergent central sleep apnea is when someone develops central sleep apnea because they’re already using a CPAP machine to treat obstructive sleep apnea.

What Is Medical Condition-Induced Central Sleep Apnea?

Medical condition-induced central sleep apnea occurs when a medical condition causes central sleep apnea. Medical conditions that can cause central sleep apnea include stroke and end-stage kidney disease. Medical condition-induced central sleep apnea is central sleep apnea that doesn’t involve Cheyne-Stokes breathing.

What Is Idiopathic Central Sleep Apnea?

Idiopathic central sleep apnea, also known as primary central sleep apnea, is uncommon and its cause is unknown.

What Are the Symptoms of Central Sleep Apnea?

The symptoms of central sleep apnea can include:

  • Snoring
  • Headaches in the morning
  • Changes in mood
  • Trouble concentrating
  • Hypersomnia, or excessive sleepiness during the day
  • Insomnia, or difficulty staying asleep
  • Abruptly waking up at night short of breath
  • A partner has observed abnormal breathing or periods of stopped breathing

What Is Obstructive Sleep Apnea?

Obstructive sleep apnea is the more common form of sleep apnea and it occurs when the muscles in the throat relax when they shouldn’t and block your airway. This blockage causes your breathing to stop temporarily while you’re sleeping.

What Complications Can Obstructive Sleep Apnea Cause?

If you have obstructive sleep apnea, the following complications could result:

  • Daytime sleepiness
  • Fatigue
  • Cardiovascular problems
  • Eye issues
  • A sleep-deprived partner
  • Medical complications
  • Surgical complications

What Can Put You More at Risk for Obstructive Sleep Apnea?

The risk factors that increase the likelihood of developing obstructive sleep apnea include the following:

  • Being overweight
  • Older age
  • Asthma
  • Narrower airway
  • Smoking
  • Diabetes
  • Chronic nasal congestion
  • Sex
  • Hypertension (high blood pressure)
  • Family history of having obstructive sleep apnea

What Can Cause Obstructive Sleep Apnea?

Obstructive sleep apnea is caused by the relaxation of the muscles in the back of your throat. These are the muscles that support the tongue, tonsils, uvula, and soft palate. If these muscles relax, then this causes your airway to either narrow or close altogether, hampering your ability to breathe. This is why obstructive sleep apnea has its name. The muscles in the throat obstruct the passage of air to the lungs.

What Are the Symptoms of Obstructive Sleep Apnea?

The symptoms of obstructive sleep apnea can include:

  • High blood pressure
  • Sleepiness during the day
  • Fatigue
  • Snoring loudly
  • Waking up with a dry mouth
  • Waking up with a sore throat
  • Headache in the morning
  • A partner observes periods of stopped breathing
  • Trouble concentrating
  • Mood changes
  • Depression
  • Irritability
  • Decrease in libido
  • Awakening abruptly in the middle of the night (often choking or gasping for breath)

What Is Complex Sleep Apnea Syndrome?

Complex sleep apnea syndrome is the combination of central sleep apnea and obstructive sleep apnea. Typically, complex sleep apnea syndrome occurs because someone was using a CPAP machine to treat obstructive sleep apnea and then as a result developed central sleep apnea as well.

Who Is Philips Respironics?

Philips is a Dutch company founded in Eindhoven in the Netherlands in 1891. It’s now headquartered in Amsterdam and is one of the largest electronics companies in the world, in particular in the health technology industry. Philips merged with Respironics, a medical device company that specialized in anesthesia masks and other medical breathing technologies, in 2007. Respironics manufactured its first CPAP machines starting in 1985 and even patented bi-level technology that, although originally intended to improve CPAP machines, ended up ultimately being used in other breathing devices that enabled the company to offer products to treat other sleep disorders as well as sleep apnea.

Why Did Philips Recall CPAP Machines?

In 2021, Philips issued a recall for certain CPAP machines, BI-PAP machines, and respirators. This recall occurred because of a defect in the PE-PUR (polyester-based polyurethane) sound abatement foam. The foam was used in the affected devices in order to reduce both sounds and vibrations in the company’s breathing devices. However, the foam in certain devices broke down, and then particles of the foam could potentially enter the tube that functioned as the device’s air pathway. From there, patients using the affected devices could end up inhaling the foam particles. Philips had received numerous complaints from people who had discovered black particles from the foam in the air pathways of their CPAP machines and other Philips respiratory devices.

Which CPAP Machines Did Philips Recall?

Philips recalled several models of CPAP machines as well as other respiratory devices that all had the same issue with foam particles entering the air pathways. Most of the affected devices are CPAP machines, although some BI-PAP machines and respirators are also included in the recall list. These recalled devices include:

  • C-Series ASV
  • C-Series S/T and AVAPS
  • Dorma 400
  • Dorma 500
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • E30
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q-Series)
  • A-Series BiPAP A30
  • A-Series BiPAP A40
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 Auto
  • Garbin Plus, Aeris, LifeVent
  • Trilogy 100
  • Trilogy 200

What Are the Symptoms Associated with a Recalled CPAP Machine?

Although no deaths have thus far been reported as a result of inhaling the black debris from the CPAP machines’ defective foam, a number of other symptoms have been reported in complaints made to Philips, including:

  • Headache
  • Cough
  • Chest pressure
  • Upper airway irritation
  • Sinus infection
  • Skin irritation
  • Eye irritation
  • Respiratory tract irritation
  • Nose irritation
  • Inflammatory response
  • Asthma
  • Dizziness
  • Carcinogenic or toxic effects on organs such as the kidney or liver
  • Hypersensitivity
  • Nausea
  • Vomiting

What Are the Issues with the Philips Recall?

If you have discovered that your CPAP machine or other Philips respiratory device was affected by the recall, you should talk to your doctor, who will discuss your options with you:

  • Stop using the recalled device
  • Use a similar device instead
  • Continue using the recalled device
  • Use a completely different treatment

Philips also provided instructions on how to replace or clean impacted devices. You can register your defective device on Philips’ website and also report any problems to the FDA.

Unfortunately for those who need replacement foam for their CPAP machines, Philips was not prepared with enough replacement foam kits for everyone who needed them. This meant that many people who needed to continue using a CPAP machine couldn’t safely do so because their replacement foam was unavailable. The recall will be continuing until September of 2022 due to a shortage of foam that has undergone the extensive testing required to know that it’s safe.

Should You Consider a Philips CPAP Lawsuit?

Many plaintiffs who are suing Philips over its handling of the defective foam issue have complained that Philips hasn’t offered loaner CPAP machines while they’re waiting for their replacement foam. Additionally, they can’t buy a new CPAP machine because of its high price. For the same reason, their insurance companies won’t cover the cost of a replacement either if the device they’re currently using is less than five years old.
If you have used a Philips CPAP machine that has been recalled due to the defective foam and have been negatively impacted by it, either due to symptoms experienced or because you weren’t able to use your CPAP machine to treat your sleep apnea, you may have a case against Philips. Contact Seeger Weiss for a free consultation regarding your case.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

Sources

  1. Brockman, J. (2021, August 17). Breathing machine recall over possible cancer risk leaves millions scrambling for substitutes. The New York Times. Retrieved April 25, 2022, from https://www.nytimes.com/2021/08/17/health/cpap-breathing-devices-recall.html
  2. Center for Devices and Radiological Health. (n.d.). Certain philips respironics ventilators, BiPAP, CPAP machines recalled. U.S. Food and Drug Administration. Retrieved April 25, 2022, from https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks
  3. Chee, F. Y., & Mika, N. (2007, December 21). Philips in $5 billion Respironics deal. Reuters. Retrieved April 25, 2022, from https://www.reuters.com/article/us-philips-idUSL2131786820071221
  4. Ellis, R. (2021, June 15). Recall: Philips breathing devices for health risks. WebMD. Retrieved April 25, 2022, from https://www.webmd.com/lung/news/20210615/philips-cpap-machines-recall
  5. Grzincic, B. (2021, September 30). MDL Watch: Panel to weigh CPAP, sunscreen actions. Reuters. Retrieved April 25, 2022, from https://www.reuters.com/legal/litigation/mdl-watch-panel-weigh-cpap-sunscreen-actions-2021-09-29/
  6. Mayo Foundation for Medical Education and Research. (2020, July 28). Sleep apnea. Mayo Clinic. Retrieved April 24, 2022, from https://www.mayoclinic.org/diseases-conditions/sleep-apnea/symptoms-causes/syc-20377631
  7. Mayo Foundation for Medical Education and Research. (2021, August 7). Central sleep apnea. Mayo Clinic. Retrieved April 24, 2022, from https://www.mayoclinic.org/diseases-conditions/central-sleep-apnea/symptoms-causes/syc-20352109
  8. Mayo Foundation for Medical Education and Research. (2021, July 27). Obstructive sleep apnea. Mayo Clinic. Retrieved April 24, 2022, from https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090
  9. MedWatch online voluntary reporting form. accessdata.fda.gov. (n.d.). Retrieved April 25, 2022, from https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
  10. Philips respironics sleep and Respiratory Care Devices: Philips healthcare. Philips. (n.d.). Retrieved April 25, 2022, from https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
  11. Stanborough, R. J. (2020, August 18). What is a CPAP machine? how it works, pros, cons, other options. Healthline. Retrieved April 24, 2022, from https://www.healthline.com/health/what-is-a-cpap-machine

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