Phillips CPAP, BIPAP & Ventilators

Sleep apnea patients beware — Philips Respironics, the world’s largest manufacturer of CPAP (Continuous Positive Airway Pressure) machines, issued a voluntary recall of CPAP, BiPAP (Bilevel Positive Airway Pressure), and ventilator machines due to their defective sound abatement foam, which is made of polyester-based polyurethan (PE-PUR). All of these devices provide breathing assistance.

For context, PE-PUR abatement foam functions to reduce noise and vibrations from these devices. However, the PE-PUR abatement foam in these recalled devices may degrade and release black particles and chemicals directly into the user’s airways. The result can be life-threatening, cause permanent impairment, and require medical intervention to better avoid permanent damage.

Although Philips Respironics ventilators, BiPAP, and CPAP machines are often used by sleep apnea patients, these devices are also used in nursing homes, hospitals, ICUs, and NICUs for patients with breathing problems in general (which includes sleep apnea). As such, the recall affects millions of devices sold between 2009 and April 2021.

Recalled CPAP, BiPAP & Ventilator Devices

On April 16, 2012, Philips Respironics warned of the potential health risks associated with the PE-PUR sound abatement foam. After ongoing review, Philips issued a voluntary recall on June 14, 2021, for the following defective devices:

CPAP and BiPAP Devices

Continuous Ventilator, Non-Life Supporting

• DreamStation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C-Series ASV
• C-Series S/T and AVAPS
• OmniLab Advanced+

Noncontinuous Ventilator

• SystemOne (Q-Series)
• DreamStation
• DreamStation Go
• Dorma 400
• Dorma 500
• REMstar SE Auto

Ventilators

Continuous Ventilator

• Trilogy 100
• Trilogy 200
• Garbin Plus, Aeris, LifeVent

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

• A-Series BiPAP V30 Auto

Continuous Ventilator, Non-Life Supporting

• A-Series BiPAP A40
• A-Series BiPAP A30

Dangers of Exposure to Chemicals & Particulates

Inhaling the particles and chemicals from the sound abatement foam degradation can cause toxic and/or carcinogenic effects that may result in serious injuries. As we said before, the injuries can be life-threatening, cause permanent impairment, or require medical intervention to prevent permanent damage. The foam degradation may worsen because of factors such as certain ozone or UV light cleaning methods, high temperatures, or high humidity.

That being said, the injuries you may suffer after being exposed to the particulates and chemicals from the defective foam include:

• Lung Cancer
• Liver Cancer
• Kidney Cancer
• Kidney Failure
• Liver Failure
• Respiratory Failure
• Serious Respiratory Issues (including Asthma, Fibrosis, Restrictive Lung Disease)
• Transplantation of Lungs, Liver, Kidneys

What to Do If You Used a Defective BiPAP, CPAP, or Ventilator Machine

You likely won’t experience immediate health effects after using Philips’ defective ventilators, BiPAP, and CPAP machines, although, the long-term consequences can be devastating for users of the company’s affected machines. As such. The FDA suggests that people who used affected BiPAP or CPAP machines consider the following recommendations:

• Talk to your health care provider to decide on a suitable treatment for your condition, which may include:
  • Stopping use of your device
  • Using another similar device that is not part of the recall
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouthguard or an orthodontic retainer.
  • Initiating long-term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.
  • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
• Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories.
• Register your device(s) on Philips Respironics’ recall websiteExternal Link Disclaimer to stay updated on any new instructions or other corrective fixes.
• Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

What to Do If You Used a Defective Ventilator

The FDA has similar recommendations for people who used affected ventilators, although, the differences are worth knowing. We encourage you to review the FDA’s suggestions below:

• Do not stop or change ventilator use until you have talked to your health care provider.
• Talk to your health care provider about using an inline bacterial filter, which may help filter out particles of foam, as indicated in the Philips recall notification. It is important to note the following considerations:
  • Filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
  • Filters may affect ventilator performance because they may increase the resistance of airflow through the device.
  • You should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.
• Register your device(s) on Philips Respironics’ recall websiteExternal Link Disclaimer.
• Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

Get Powerhouse Representation Today

Our team of attorneys is representing victims across the US who have suffered from defective ventilators, BiPAP, and CPAP machines made by Philips Respironics. We have extensive trial experience and have recovered millions of dollars in settlements for our injured clients, giving us the insights and resources needed to fight for fair, maximum compensation on your behalf. With over 40 years of combined experience, you are in good hands at Kwartler Manus, LLC.