Why Did Philips Recall Their CPAP and BiPAP Machines?

On April 13, 2021, Philips announced it was launching the DreamStation 2, the next-generation machine in its DreamStation product family. About two weeks later, the company alerted doctors and other healthcare providers to the recall of some of the earlier DreamStation machines.

In an urgent medical device recall, Philips stated that the PE-PUR foam in the affected machines may “degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user,” and that the foam may also “off-gas certain chemicals.” The foam degradation could be made worse by the use of unapproved cleaning methods, specifically, ozone cleaners. High heat and high humidity environments could also contribute to foam degradation in certain regions.

Lab analysis of the degraded foam reveals the presence of potentially harmful chemicals including toluene diamine, toluene diisocyanate, and diethylene glycol. Chemical emissions may include potentially harmful volatile organic compounds (VOCs) like dimethyl diazine outside of safety thresholds.

“These issues can result in serious injury which can be life-threatening,” the recall notice reads, “cause permanent impairment, and/or require medical intervention to preclude permanent impairment.”

The company noted that it had received “several complaints” regarding the presence of black debris and/or particles within the airpath circuit. It also received reports of patients suffering from headaches, upper airway irritation, cough, chest pressure, and sinus infection that could be related to this issue. At the time of the recall, the company had received no reports of serious illnesses, injuries, or death connected to these machines.

Philips noted at the end of this notification that it was “deploying a permanent corrective action” to address the problem with these devices—namely, to replace the defective foam. Patients were encouraged to register online, after which they would be notified with additional information “as it becomes available.” It is unclear how long it will take for patients to have access to these repairs.

U.S. FDA Announces Philips Recall of CPAP and BiPAP Machines

On June 30, 2021, the U.S. Food and Drug Administration (FDA) alerted patients and their healthcare providers to the Philips recall. The agency included a list of all affected products and their model numbers and names.

Patients were advised to talk to their doctors about the issue and to possibly consider using other similar devices for treatment. Those using the ventilators were advised not to stop using them until talking to a healthcare provider. If alternate ventilator options aren’t available, the FDA advised using an inline bacterial filter, which could help filter out particles of foam. Such filters don’t help reduce exposure to certain chemicals that may be released from the foam, however.

The FDA also reminded CPAP and BiPAP machine users to follow the manufacturer’s recommended cleaning guidelines.

“Ozone cleaners may worsen the breakdown of foam,” the FDA stated. There are other potential risks as well with using ozone products for cleaning these machines and their accessories. These include:

• Exposure to ozone gas (if leaks occur at tubing connections, filters, or through fabric containers)
• Nasal, lung, or other types of irritation
• Worsened chronic respiratory disease
• Cough
• Difficult breathing
• Headaches

The FDA added that using ultraviolet (UV) light cleaning products may also pose potential health hazards. Though the agency has not received any problem reports associated with using these devices, it noted that unintentional or excessive exposure to UV light during cleaning could put a user at risk of eye injury, skin burns, or even an increased risk of skin cancer.

Types of Injuries Associated with the CPAP and BiPAP Machines

Treatment with the Philips CPAP, BiPAP, and ventilator machines may result in the following symptoms and injuries:

• Headaches
• Upper airway irritation
• Eye irritation
• Cough
• Chest pressure
• Sinus infection
• Airway inflammation
• Asthma
• Adverse effects on other organs (kidneys and liver)
• Toxic carcinogenic effects

What are the Philips CPAP and BiPAP Machines?

Philips manufactures and sells CPAP and BiPAP machines, as well as ventilators, among other products. Its flagship CPAP/BiPAP machine product family is known as the “DreamStation” family line, which includes the original DreamStation, launched in October 2015, and the DreamStation Go, a travel version. Philips sells these products through its subsidiary Respironics, which it acquired in 2008.

Many—though not all—of the DreamStation CPAP and BiPAP machines and some of the ventilators contain PE-PUR foam for sound abatement. Due to the design of the machines, the air passes through this foam before it is pumped into the patient’s airway.

Philips Pushes Its Newer Respiratory Machines

In its first-quarter update released on April 26, 2021, Philips noted that it had determined from user reports and testing that “there are possible risks to users related to the sound abatement foam used in certain of Philips’ sleep and respiratory care devices currently in use.” Most of the affected devices were in the first-generation DreamStation product family.

Then Philips went on to note that it had recently launched its next-generation CPAP platform, DreamStation 2, which “is not affected” by the foam problems.

On June 14, 2021, Philips issued a press release updating the public on the recall. The company advised patients using the CPAP and BiPAP machines to:

• Discontinue the use of the devices.
• Talk with their physicians to determine the “most appropriate options for continued treatment.”
• Consult with their doctors “to determine if the benefit of continuing therapy with your device outweighs the risks identified in this recall notification.”

For patients affected by the ventilators, Philips advised them not to stop using the devices until they could talk to their doctors. Due to a lack of alternative devices, the company advised patients and doctors to weigh the benefits and risks of continuing to use the Philips devices.

The company stated that it was working on a remedy for this recall, and would replace the current sound abatement foam with new material. At the time of this press release, management had started preparations for the launch and implementation of the correction, but it was not yet available for patients. Those requiring the use of these machines, therefore, were left in limbo and on their own in finding alternatives.

At the end of the release, Philips noted that it had recently launched its new DreamStation 2 products and that these were not affected by the same foam problem. To “support” the recall correction program, the company stated it was “increasing the production of its DreamStation 2 CPAP devices, that are available in the U.S. and selected countries in Europe.”

CPAP, BiPAP, and Ventilator Machines Critical to Treatment of Breathing Disorders

All of the recalled product lines provide breathing assistance to patients who have certain conditions or illnesses that make breathing difficult.

• CPAP: A continuous positive airway pressure (CPAP) machine provides a continuous stream of air through a mask. It is prescribed to patients diagnosed with obstructive sleep apnea to keep their airways open during sleep.
• BiPAP: Similar to a CPAP machine, a bilevel positive airway pressure (BiPAP) machine also provides air through a mask, but it pumps the air at a higher pressure when the patient breaths in and at a lower pressure on the exhale.
• Ventilator: This continuous ventilator device helps patients who cannot breathe on their own, or those who suffer from severe respiratory diseases. It mechanically controls or assists breathing by delivering a predetermined percentage of oxygen into the breathing gas.

All of these machines provide important treatment to patients diagnosed with sleep apnea or other respiratory ailments. Without them, patients can be at an increased risk for other diseases and complications.

What is Sleep Apnea?

Sleep apnea is a potentially serious sleep disorder that causes an individual’s breathing to stop and start repeatedly. There are three main types:

1. Obstructive sleep apnea: The throat muscles relax during sleep, obstructing the airway. This is the most common type.
2. Central sleep apnea: The brain doesn’t send the proper signals to the muscles that control breathing. This is a more rare form of the disorder.
3. Complex sleep apnea: A combination of the previous two.

Symptoms of sleep apnea include the following:

• Loud snoring
• Gasping for air during sleep
• Repeated episodes of stopped breathing during sleep—usually unnoticeable to the individual, but noticeable to another person sleeping nearby
• Morning headaches
• Daytime sleepiness
• Difficulty concentrating while awake
• Irritability

Those noticing these types of symptoms should check with a doctor. Without treatment, sleep apnea can increase the risk of driving and workplace accidents. Over time, it can also increase the risk of cardiovascular disease, overweight and obesity, type 2 diabetes, and liver problems.

What is Respiratory Failure?

Mechanical ventilators like the Philips ventilator are typically used when a patient is experiencing respiratory failure. Many underlying conditions can cause this failure, including:

• Physical trauma
• Sepsis
• Pneumonia
• COVID-19
• Drug abuse

Without treatment, respiratory failure can be fatal. Mechanical ventilators push air in and out of the patient’s lungs like bellows. They can also be used during surgery when general anesthesia may interrupt normal breathing.

Philips CPAP, BiPAP, and Ventilator Lawsuits

Though Philips did not notify the public about these potential health risks until June 2021, the company is believed to have known about them for a long time. Customers have complained about black particles in their machines, for example, for several years, as evidenced by forum posts.

If you or a loved one has used or is using a Philips CPAP, BiPAP, or ventilator machine that is affected by this recall, you may be eligible to file a personal injury lawsuit to recover damages. At the time of this writing, a truck driver—who is required to use a BiPAP machine to treat his sleep apnea—has already filed a class-action lawsuit to represent all others similarly situated who had to go without this important treatment because of the Philips recall.  Additionally, a complaint has already been filed in the United States District Court for the Middle District of Georgia where the plaintiff alleges that prolonged use of one of the recalled devices caused his lung cancer.

Chaffin Luhana is now investigating these cases and invites you to call today at 888-480-1123.