Philips Respironics, a prominent medical equipment manufacturer, recently recalled some Continuous Positive Airway Pressure (CPAP) machines. Due to health dangers from sound abatement foam, millions of devices, including CPAP and BiPAP equipment, were recalled. Some machines’ foam degrades and releases particles into the airway, causing respiratory discomfort and other major health consequences.

The recall is a matter of utmost importance for people who rely on CPAP machines to treat sleep apnea. It is essential that those who may be affected take appropriate action to ensure their safety and wellbeing. In the following sections, we will discuss the details of the Philips recall, the potential risks associated with the affected devices, and what steps users can take to address the issue.

The Philips Recall

Philips, the world’s largest medical equipment producer, recently recalled some of its CPAP and BiPAP machines owing to health risks.

In June 2021, Philips Respironics recalled equipment that included foam that could disintegrate and discharge hazardous particles into the airway. The devices posed a risk of causing serious injury or even death to patients who use them.

The following Philips CPAP and BiPAP models are part of the recall:

• A-Series BiPAP A30
• A-Series BiPAP A40
• A-Series BiPAP V30
• Trilogy Evo Ventilator
• Trilogy 100
• Trilogy 200

Philips prompted the recall due to reports of foam degradation in the devices. The machines can draw in and expose the user to particles from the sound abatement foam that breaks down.

Additionally, the foam may emit volatile organic compounds that can have potential health risks. Philips identified two types of foam used in the affected devices, polyester-based polyurethane (PE-PUR) sound abatement foam and polyether-based polyurethane (PE-PUR) foam. Both types of foam can break down and potentially cause harm to the user.

Philips Issues Class 1 Recall for Millions of Sleep Apnea Devices

The recall is classified as a Class 1 recall, which is the most serious type of recall issued by the U.S. Food and Drug Administration (FDA). Class 1 recalls are issued when there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death. The FDA has advised patients to stop using the recalled devices and consult with their healthcare provider to determine the most appropriate treatment option.

As of August 2021, Philips had received reports of potential health risks associated with the affected devices. The company reported that approximately 3.5 million devices manufactured between 2009 and April 2021 were part of the recall. Philips has stated that it will repair or replace the recalled machines with a replacement device, which has undergone a safety test and is approved by the FDA.

It is essential to address the recall promptly and replace affected devices, as the health risks associated with the use of recalled machines can be serious. Patients who rely on CPAP or BiPAP machines for sleep apnea treatment should consult with their healthcare provider immediately and follow the recall notification instructions provided by Philips.

Related Article: CPAP Machine Recall: Everything You Need To Know

Specifics Of The Affected Models

The following are some details about each affected model: 

A-Series BiPAP A30 

This machine is designed to provide non-invasive ventilation to patients with respiratory insufficiencies. It has advanced ventilation modes, adjustable trigger and cycle sensitivities, and a flexible patient circuit.

A-Series BiPAP A40 

This machine is designed for the treatment of obstructive sleep apnea and respiratory insufficiencies. It features an auto-trial mode to help find the optimal pressure, a ramp function to make it easier to fall asleep, and data recording capabilities.

A-Series BiPAP V30 

This machine is designed to provide non-invasive ventilation to patients with respiratory insufficiencies. It features advanced ventilation modes, an auto-trial mode, and a flexible patient circuit.

Trilogy Evo Ventilator 

This ventilator is designed for the treatment of respiratory insufficiencies in both adult and pediatric patients. It features multiple ventilation modes, remote patient monitoring, and a touch screen interface.

Trilogy 100 And 200 

These ventilators are designed to provide non-invasive and invasive ventilation to patients with respiratory insufficiencies. They feature multiple ventilation modes, remote patient monitoring, and data recording capabilities.

The degradation of these devices’ sound abatement foam’s polyester-based polyurethane (PE-PUR) foam has caused unexpected failure in some situations.

The compromised devices may expose users to toxic foam particles and volatile organic chemicals, which can cause respiratory difficulties, inflammation, and cancer. These gadgets for sleep apnea treatment or minimum ventilatory assistance may increase health risks.

Philips recommends that users of affected devices should discontinue using the recalled machines and should seek a replacement device through Philips’ repair and replace program or from their healthcare provider. Avoid using unapproved cleaning methods or ozone-related cleaning products.

Impact Of The Philips CPAP Machine Recall

The Philips CPAP recall had a substantial impact on affected equipment users, the medical community, and Philips as a company. Sleep apnea patients who rely on CPAP therapy to manage their condition have been forced to discontinue use of their recalled machines or switch to alternative treatments, which can be both expensive and time-consuming. Foam particles and volatile organic chemicals may provide health concerns to patients using the afflicted equipment.

The recall has also affected the medical community, as healthcare providers must now manage patients who may not have access to their usual sleep apnea treatment. Medical equipment suppliers and durable medical equipment providers may face delays in obtaining replacement devices for affected patients. Additionally, the recall has led to increased scrutiny of the safety and efficacy of CPAP devices, and independent testing may be necessary to ensure that the replacement devices meet safety standards.

For Philips as a company, the recall has had financial and reputational impacts. The cost of repairing or replacing millions of recalled devices is significant, and the company has faced lawsuits from customers who claim that the recalled devices caused them harm. The recall has damaged Philips’ reputation as a trusted medical device manufacturer, and the company has been criticized for failing to identify the issue with the sound abatement foam earlier.

The Philips CPAP recall has had a significant impact on patients, the medical community, and Philips as a company. While the company has taken steps to address the issue and provide replacement devices, the full extent of the impact of the recall may not be known for some time.

Legal Options For Those Affected

Individuals affected by the Philips CPAP recall may have legal options available to them. If a person has suffered injuries or damages as a result of using a recalled device, they may be able to file a lawsuit against Philips.

To file a CPAP lawsuit against Philips, affected individuals will need to find an attorney who specializes in medical device litigation. The attorney will review the case and determine if there is enough evidence to proceed with a lawsuit. They will also be able to provide information on the specific legal options available based on the individual’s circumstances.

There is an ongoing class action lawsuit against Philips related to the CPAP recall. The lawsuit alleges that Philips was negligent in its design, manufacture, and sale of the recalled devices, and failed to warn consumers of the potential health risks associated with the sound abatement foam used in the devices.

Potential compensation for those affected by the recall may include medical expenses, lost wages, pain and suffering, and other damages. The amount of compensation will depend on the individual’s specific circumstances and the extent of their injuries.

Individuals involved in class action lawsuits may have access to legal funding. This funding may cover legal fees and other expenses associated with the lawsuit. It is important to consult with an attorney to determine if legal funding is available and appropriate for a particular case.

Other CPAP Recalls And Concerns

ResMed recalled several CPAP equipment in 2020 owing to potentially defective sound abatement foam, similar to Philips’ issue. Ventec Life Systems recalled its VOCSN portable ventilators in 2021 due to concerns about lithium-ion batteries.

Long-term usage of CPAP devices may lead to pressure sores, infections, and other issues. Some research suggest that CPAP equipment may not work for all sleep apnea patients and that alternate treatments may be better.

Monitor the FDA website and sign up for CPAP manufacturer email notifications to stay updated about recalls and safety issues. Users should also follow all CPAP device maintenance and cleaning instructions to avoid issues. Finally, CPAP users should discuss safety and efficacy with their doctor.

Conclusion

The recent recall of Philips CPAP machines has raised significant concerns for sleep apnea patients who rely on this treatment. The sound abatement foam in millions of machines may pose health dangers, prompting the recall. Recall victims should take action, including legal action, to address health risks and get replacement equipment.

CPAP machine safety and efficacy concerns underscore the significance of recall and safety updates. This recall raises concerns about the medical community’s duty to safeguard medical device safety and the need for improved regulation and control. Prioritize patient safety and handle any concerns as the situation develops.

For those affected by the recall and in need of new, safe CPAP accessories, our Amazon shop offers a wide selection of quality products to ensure your sleep therapy continues uninterrupted and effectively.