URGENT: Recall on Some Ventilators, BiPAP, CPAP Machines

Certain Philips Respironics ventilators, BiPAP, CPAP machines recalled for potential health risks

According to a safety communication from the U.S. Food and Drug Administration (FDA), certain Philips Respironics ventilators, BiPAP, and CPAP machines have been recalled because of potential risk for injury or illness. The danger comes from a foam used in the devices that can break down and be inhaled by the user. 

This foam, meant to lessen the sounds and vibrations inside these devices, is made of polyester-based polyurethane (PE-PUR). As the foam ages and degrades, black particles may appear throughout the machine’s air pathway. In addition, it could off-gas carcinogenic chemicals.

A brief overview of the recalled devices

The following devices are being recalled:

CPAP and BiPAP devices

This recall affects both:

• Bilevel positive airway pressure machines, also known as BiPAP or BPAP 
• Continuous positive airway pressure (CPAP) machines

These machines have similar uses but work in different ways. Both keep the airway open by using pressurized air pumped through a mask. A BiPAP machine has higher pressure when the user inhales and lower during the exhale. CPAP machines use constant pressure to keep airways open despite obstructive sleep apnea.

Ventilators

Ventilators are life-sustaining or supporting devices that provide a steady percentage of oxygen while controlling or assisting the user’s breathing. Philips Respironics makes a number of these devices.

BiPAP or CPAP: Recommendations for people who use the affected BiPAP or CPAP machines and their caregivers

If you have a condition that requires the use of a CPAP or BiPAP machine, you should talk to your doctor before you stop using the device, even if there has been a recall. You will need to discuss a more suitable treatment for your condition. Your options may include:

• Stopping using the device for an alternative therapy
• Switching to a machine that is not part of this recall
• Avoiding triggers for sleep apnea and taking preventative steps, such as losing weight
• Surgery

In some cases, your doctor may recommend that you continue using the device until you receive one of the Philips repair kits available for some models. On October 18, 2021, Philips Respironics reported they have 750,000 of these kits and/or replacement devices available and about 250,000 installed in the recalled machines.

Ventilators: Recommendations for people who use affected ventilators at home and their caregivers

Because of the life-sustaining nature of ventilators, it is imperative that you do not stop or alter your use of a recalled ventilator without first speaking with your doctor. In some cases, the benefits of using these devices may heavily outweigh the risks. Alternative options may be limited at this time. However, you should allow the treating physician to make this decision. Contacting them as soon as possible is the best move.

Your doctor may recommend an inline bacterial filter. While the FDA has not confirmed this is effective for trapping the foam particles, it could help. However, it will not reduce exposure to the chemicals released from the PE-PUR foam. It could also affect the performance of the machine because it will slightly alter the airflow. It may accumulate foam debris, so it should be checked often.

Description of the affected CPAP, BiPAP, and ventilation devices

The machines included in the 2021 Philips Respironics medical device recall are all products meant to use pressurized air to open the user’s airways and allow them to breathe normally. These devices include:

• BiPAP that provides support for sleep apnea and other applications
• CPAP that provides continuous pressure for severe obstructive sleep apnea and other conditions
• Mechanical ventilators that assist in breathing or ensuring the oxygen concentration in the blood

All three types of devices feature a mask worn by the user and connected to a machine by a hose. These machines pump pressurized air from the machine into the mask, where it enters the user’s airway and fills their lungs.

When the foam used to keep the machines operating quietly begins to break down, particles and gas from this foam can also make their way into the hose, mask, airway, and lungs. This is what could cause serious injury, illness, or death and why the company recalled the affected products.

PE-PUR foam may be inhaled or swallowed, presenting a potential health risk

PE-PUR sound abatement foam is commonly used in medical equipment to make it operate quietly. While this is not usually a problem, it may be if it breaks down and gets into the airway of a CPAP, BiPAP, or ventilator device. The issues occurring that support this voluntary recall include: 

• The foam breaking down into particles that can then be inhaled or swallowed by the user
• The degrading foam releasing dangerous chemicals which the user may inhale

When either of these happens, the user is at risk of serious injury requiring medical care or even lasting impairment or death. While there have been no reported deaths as of November 2021, Philips Respironics received complaints about black foam debris entering the air pathway of these machines.

Symptoms and risks associated with breathing in these particles and chemicals

Reported symptoms potentially linked to this foam debris includes: 

• Headache
• Upper airway irritation
• Cough
• Chest pressure
• Sinus infection

While these reports are not severe at this time, the company is aware of additional risks that could occur, which is why they recalled the devices. Hazards of breathing in the foam particles include:

• Skin, eye, and respiratory tract irritation
• Inflammatory response
• Headache
• Asthma 
• Liver and kidney damage use to the inhalation of toxic or carcinogenic substances

The possible risks associated with breathing in the chemicals released into the air pathways by off-gassing PE-PUR foam include:

• Skin, nose, eye, and respiratory tract irritation
• Headache
• Dizziness
• Hypersensitivity
• Nausea/vomiting 
• Organ damage from the toxic and carcinogenic effects

If you used one of these devices and experienced any of these symptoms, you should report them to your doctor right away. After your medical care and assessing your options for an alternative, you can speak with a mass tort lawsuit lawyer about your next steps.

Reporting problems with your device

If you experienced the effects of black debris, symptoms after use, or other issues with a CPAP device, BiPAP machine, or mechanical ventilator, you can notify the FDA of the issue and what happened by completing the MedWatch Voluntary Reporting Form. This is one way the FDA tracks the risks associated with medical devices and allows them to include your symptoms in future assessments for safety and usage recommendations.

You should also talk to your doctor to determine if you require any treatment for your symptoms and discuss if there are better, safer treatment options for your condition. Getting the best care possible is critical in reducing your severe injury or illness risk.

Lastly, you may want to meet with a mass tort attorney who is looking into these cases. You could have a case that will support a claim or lawsuit, or you may be able to join a mass tort if one forms later on. Most personal injury attorneys who handle defective device claims provide free consultations.

Philips CPAP machines are being recalled; what to know

In July, the FDA determined this concern was deserving of a Class I recall classification. This is the most serious type of recall and acknowledges that the continued use of these machines without repair could be life-threatening.

What is the issue with the recalled machines?

Philips Healthcare’s respiratory care division, Philips Respironics, voluntarily recalled certain ventilators, BiPAP, and CPAP machines in June 2021. There have been no deaths, but there are several reports of adverse events and the risk of potential health complications, including life-threatening injuries and illnesses. 

This recall is in place because of the sound abatement foam, known as PE-PUR, used to help these machines run more quietly. This foam can break down over time, releasing both particles and gasses into the device’s airway.

When users breathe in particles or gases or swallow them, serious health complications could result.

What health concerns can these machines cause?

As the PE-PUR foam degrades, it breaks down into tiny black pieces of foam and off-gases certain chemicals. Because these devices rely on forced air, the user could easily inhale or swallow any particle or gas in the machine’s airway.

Inhaling or swallowing any foreign substance can be dangerous and even life-threatening, especially for those who already have respiratory issues. 

With this foam, there are also concerns that the gases and particles might be toxic or carcinogenic, meaning they could poison the user, cause organ damage, or lead to cancer.

Are your cleaning methods increasing your risk?

In some cases, your environment or cleaning methods could increase your risk of injury or illness when using a recalled device. The recall information issued by the FDA warns that high heat and humidity could cause the foam to degrade faster. The agency also warns against using any unapproved cleaning methods because of increased risk.

The FDA questions the safety of cleaning methods, including ozone and ultraviolet light in all sleep apnea and ventilation devices.

Should you stop using a recalled device?

It is vital that you do not stop using your CPAP, BiPAP, or ventilator without first talking to your doctor. However, it is essential to contact your physician or clinical care team as soon as possible to discuss your recalled device and what actions you should take. You will likely need to find an alternative or get a repair kit.

They may also want to assess you for any injuries or potential risks related to your previous use of the machine.

How to determine if your device is recalled

According to the recall letter issued by Philips Respironics, several devices are included in this recall. The FDA published a list that includes: 

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

All recalled devices were manufactured and purchased between 2009 and 2021. All serial numbers of the recalled models were affected if purchased between these dates. 

The FDA’s recommendations for action if you have a recalled device include: 

• BiPAP or CPAP devices
• Ventilators

If you believe your machine or the device used by a loved one might be a part of this recall, you should talk to your health care provider as soon as possible. They can check to see if the recall affects you, help you determine if you need to continue using the machine, provide an alternative treatment or different device, or help you get a repair kit. 

Philips provided a video so that users of CPAP, BiPAP, and ventilator products could better understand how to:

• Determine if your device is a part of the recall
• Register your device with Philips Respironics so the company can notify you of any future recalls, repair kit availability, or additional necessary action

Legal options for those affected by the device recall

As of November 2021, many defective medical device law firms are investigating potential injury cases based on these dangerous devices. It may be possible to hold Philips Respironics, the foam manufacturer, or another party legally responsible for any injuries that occurred.

If you experienced any adverse effects that you believe may be linked to your use of a recalled device, you may have a case. You can discuss your legal options with an attorney who handles defective product cases and mass torts. There is a chance this case could support a mass tort lawsuit in the future.