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Philips CPAP Recall Information
On June 14, 2021, Philips Respironics issued a nationwide recall [1] for various CPAP, BiPAP, and mechanical ventilators after the sound-reducing polyester-based polyurethane (PE-PUR) foam used in the devices was found to:
- Degrade and break down into black particles that can enter the device’s air-path and be swallowed by the user, and
- Expose the user to dangerous and potentially carcinogenic chemicals that can then be inhaled.
The foam degradation can cause serious injuries and may be exacerbated by the use of unapproved cleaning methods (like ozone), as well as by high-heat and high-humidity environments.
The U.S. Food and Drug Administration deemed it a Class I recall based on the potential for “serious injury or death,” and approved Philips’ plan to repair existing units by replacing the foam with a more stable alternative.
Due to the lack of ready replacement kits, though, the recall will last until September 2022. Meanwhile, Philips has not offered “loaners,” and Medicare and most insurers will not pay for a new unit – estimated at $500 to $1,000 retail – unless the prior one was at least five years old.
In its recall notice, Philips said they are “treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.”
Sleep Apnea Machines Side Effects / Injuries
Philips has received numerous complaints from customers about black debris or particles in the air-path circuit of their mechanical ventilators, BiPAP, and CPAP devices, though the cause of the health risks has not been definitively linked at this time.
Potential health risks associated with the recalled Philips sleep apnea devices can be life-threatening and include:
- Cancer (carcinogenic effects)
- Respiratory issues
- Toxic effects
- Headache
- Irritation
- Inflammation
- Chest pressure
- Other health issues
If you’ve used Philips Respironics sleep devices and experienced any of the health risks listed above, you may be able to pursue compensation through the filing of a REMStar SE Auto Recall lawsuit. Learn more about your legal options today in a free consultation.
Which Sleep Apnea Machines Were Recalled?
Different models of a variety of Philips sleep and respiratory care devices have been affected by the recall, specifically:
- Bi-level Positive Airway Pressure (Bi-level PAP or BiPAP) Devices
- Continuous Positive Airway Pressure (CPAP) Machines
- Mechanical Ventilators
Of the estimated 3-4 million recalled Philips devices, roughly 80% of the affected products are CPAP machines, particularly those in the first generation of DreamStation machines.
Philips Ventilator, BiPAP, and CPAP Recall List
Philips Respironics mechanical ventilators, BiPAP, and CPAP machines affected by the recall include:
- DreamStation ASV
- DreamStation ST
- AVAPS
- SystemOne ASV4
- C Series ASV
- OmniLab Advanced Plus
- SystemOne (Q Series)
- DreamStation CPAP Device
- DreamStation Auto BIPAP and Philips CPAP machine
- DreamStation BiPAP Machines
- DreamStation Go Ventilator Machines
- Dorma 400 and 500
- CPAP REMStar SE Auto CPAP
- Trilogy 100 and 200
- Garbin Plus
- Aeris LifeVent
- A-Series BiPAP machine
- Philips Ventilator Devices
What's the Problem With Pe Pur Foam?
Intact PE-PUR foam might be relatively harmless, but if the foam breaks down it can release particles and chemical gases, according to Philips Respironics. If these particles or gases enter the body through the nose or mouth they can cause a variety of health issues.
Even if there are no visible particles, the foam may already be breaking down and releasing harmful chemicals.
Philips Respironics lab analysis found degraded foam produced several potentially harmful chemicals in ventilator machines, including:
- Toluene diamine - A chemical used to make polyurethane, dyes, hydraulic fluid and sensitizers for explosives. Health hazards include: Genetic defects, skin reactions, toxicity, cancer, damaged fertility and organ damage.
- Toluene diisocyanate - A chemical used to make foams and coatings. Health hazards include: Eye damage, skin irritation, may be fatal if inhaled, respiratory irritation and cancer.
- Diethylene glycol - A chemical used to make other chemicals that can irritate skin, eyes and mucous membranes and may be slightly toxic if swallowed.
- Dimethyl diazene - A chemical used to make other chemicals.
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) - A chemical used to make other chemicals.
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How Does a CPAP Machine Work?
CPAP machines deliver a constant flow of air through tubing and a mask and into your airway. The device creates enough pressure in your airway to hold the tissue open, so your airway doesn't collapse.
The soft, steady jet of air from the CPAP machine creates enough pressure to keep the airway open.
Sleep specialists prescribe specific CPAP pressures for patients based on how much pressure they will need to keep their airway open. Your sleep specialist may have you try different levels of CPAP pressure when you’re in the sleep laboratory, to see which is the right level for you.
CPAP vs. BIPAP for Sleep Apnea
BiPAP refers to Bilevel or two-level Positive Airway Pressure. Like CPAP, this sleep apnea treatment works by sending air through a tube into a mask that fits over the nose. While CPAP generally delivers a single pressure, BiPAP delivers two: an inhale pressure and an exhale pressure. These two pressures are known as inhalation positive airway pressure (IPAP) and exhalation positive airway pressure (EPAP).
CPAP and BiPAP machines look similar, have the same attachments, and both use the same CPAP mask and supplies. However, each sleep apnea treatment is used for a special purpose and has its own advantages. CPAP machines are primarily used to treat obstructive sleep apnea, while BiPAP machines are used to treat central sleep apnea, complex sleep apnea, or COPD.
As far as cost, BiPAP historically has been more expensive than CPAP, which may sway consumers whose sleep apnea can be treated with either.
The comfort and liking of each machine depends on the individual, but generally, BiPAP is often used when CPAP is not tolerated by the user. One of the many advantages of the BiPAP machine is that the strain is decreased during expiration. This limits the amount of energy expended during exhalation. In other words, it is easier to breathe out with BiPAP than with CPAP.
What Do Ventilators Do?
A ventilator is a machine that helps people breathe (ventilate). These machines are often used in hospitals as life support for patients who have difficulty breathing or who have lost all ability to breathe on their own.
Mechanical ventilation may be either invasive or non-invasive (e.g. using a tight-fitting external mask). Invasive modes require the insertion of internal tubes/devices through endotracheal intubation or tracheostomy.
Mechanical ventilation is typically used on a temporary basis, such as during surgical procedures. When a patient is under general anesthesia, their normal breathing may be disrupted. A ventilator is used to ensure the patient continues to breathe while asleep during surgery.
A person with a serious lung disease or other medical condition that interferes with normal breathing may need to use a ventilator until they recover. This type of care is commonly provided in the intensive care unit (ICU) or critical care unit (CCU) of a hospital.
Even if a patient with impaired lung function can breathe on their own, they may feel short of breath. Severe shortness of breath (dyspnea) can be very distressing and uncomfortable, but a ventilator can help ease the breathing process, allowing the patient to rest and heal.
Many diseases and other factors can affect lung function and cause difficulty breathing to the point that a person may need a ventilator to stabilize their condition.
Philips CPAP Recall MDL
In October 2021, a federal judicial panel granted motions to consolidate pretrial proceedings for more than 110 federal Philips CPAP lawsuits against CPAP-maker Philips.
The Philips CPAP Lawsuit litigation is: MDL No. 3014 - In Re: Philips Recalled CPAP, Bi−Level PAP, and Mechanical Ventilator Products Liability Litigation.
The JPML chose Senior U.S. District Judge Joy Flowers Conti in Pittsburgh to handle consumer class-action Philips CPAP lawsuits over the risks posed by the sound-abatement foam used in several models of Philips’ CPAP, Bi-Level PAP and mechanical ventilators.
The panel noted that the recalled devices were “primarily manufactured by Philips RS North America LLC (formerly Philips Respironics)” in the Pittsburgh area, and that the Pittsburgh-based court was acceptable to both Philips and the plaintiff who had asked for the cases to be consolidated, Thomas Starner.
At the urging of the parties, the panel also agreed that the MDL should include personal-injury claims. About 30 of the 114 cases filed as of Oct. 8 allege personal injuries, and all of the actions “raise similar factual questions regarding the recalled devices and the conduct of the recall,” according to the JPML transfer order.
REMStar SE Auto Recall Settlement and Verdict Information
When you file a Philips CPAP lawsuit, you may be able to receive financial compensation for your injuries in one of the following forms:
Philips CPAP Lawsuit Settlement: By reaching a Philips CPAP settlement with the defendant, you may be able to avoid going to court and start receiving compensation sooner.
Philips CPAP Jury Verdict: If a settlement isn’t reached, your case will continue to court, where a judge and jury will hear your case and reach a CPAP verdict. Our lawyers are prepared to fight on your behalf in court, but there’s no guarantee of compensation in these cases.
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Get a Free CPAP Recall Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in CPAP lawsuits. We are handling individual litigation nationwide and currently accepting new Philips sleep apnea machine cases in all 50 states.
If you or a loved one was injured by a recalled CPAP machine, you should contact our law firm immediately. You may be entitled to a settlement by filing a Philips CPAP lawsuit, and our lawyers can help you receive fair compensation.
