The Philips company is in the process of recalling millions of continuous positive airway pressure (CPAP) machines, which many people in the United States utilize to treat sleep apnea. The company’s concern is related to a substantial risk of chemical exposure presented by noise-reducing foam in the device, which is manufactured from polyester-based polyurethane. The recall involves approximately three to four million Bi-Level Positive Airway Pressure, Continuous Positive Airway Pressure, and mechanical ventilator devices.
Which Philips CPAP & Ventilator Devices are Subject to Recall?
In June 2021, a recall was issued in response to a notification from April 2021 during which Philips noted that a “quality issue” involving the machines had been noted. The United States Food and Drug Administration noted that the purpose of the recall was to reduce potential health risks related to the sound abatement foam component included in the devices. The following breathing machines manufactured by Philips are subject to recall:
- CPAP and BiLevel PAP machines. Continuous ventilators that are non-life supporting that have been recalled include DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C Series ASV, S/T, AVAPS, and OmniLab Advanced Plus In-Lab Titration Device. Non-continuous ventilators include SystemOne Q Series, DreamStation CPAP, Auto CPAP, BiPAP, DreamStation Go CPAP, APAP, Dorma 400, 500 CPAP, and REMStar SE Auto CPAP. Continuous ventilators with minimum ventilatory support that have been recalled include the E30.
- Mechanical ventilators. Some examples of continuous ventilators that have been recalled include Trilogy 100 Ventilator, Trilogy 200 Ventilator, Grabin Plus, Aeris, and LifeVent Ventilator. Some examples of continuous ventilators with minimum ventilatory support that have been recalled include the A-Series BiPap V30 Auto Ventilator.
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Injuries Reported Due to the Defect in Philips CPAP & BiPAP
Fortunately, no reports of fatalities are connected to the Philips company, but reports have been received involving individuals who have been negatively impacted by foam degradation. Some of the risks of exposure have been identified as including headaches, inflammation, irritation, respiratory issues, and potential carcinogenic effects. Even though the company has so far received a low number of complaints about machines sold, testing by the company has assessed that there are potential dangers that the machine presents to users. Some of the potential medical complications associated with the off-gassing include headache, hypersensitivity, irritation, nausea, and vomiting. Philips has not yet received any reports related to patients who have been negatively impacted due to chemical emissions.
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What Makes the Defect Dangerous?
In its note, the company states that particles can enter a device’s airway where they are then either inhaled or ingested by the user and the foam may produce certain dangerous chemicals. Philips has also noted that the foam degradation might be exacerbated by the use of unapproved cleaning methods as well as locations with high heat and high humidity. In response to the patients who might have been negatively impacted by the CPAP machines, Philips has stated that the company regrets any uneasiness caused to patients as a result of the devices. Philips also noted that it is working in close collaboration with customers and partners to reach a resolution to resolve the CPAP machine dilemma.
The Company’s Recommendation for People Who Use Philips CPAP and BiLevel PAP
The company is currently urging patients who use BiLevel PAP and CPAP devices to discontinue use and to work with their physician to assess the most appropriate options for further treatment. You should still, however, make sure to get in contact with your medical provider or equipment provider so you can discuss other available options for treating your conditions as well as to make sure you promptly receive a device that does not present a risk of foam degradation. Remember, while inhaling toxic particles presents substantial health risks, sleep apnea can also present serious health risks if left untreated.
Philips also states that patients using life-sustaining ventilators should neither stop nor change their treatment until they first speak to their physician. Interrupting your treatment could have serious life-threatening consequences. You should speak to your physician as soon as possible to learn about your various options as well as the benefits and risks of continuing to use the devices. In some situations, a medical provider can help you locate an alternate ventilator that will prove the necessary therapy you need. If no good alternative exists, Philips recommends that patients install an inline bacterial filter.
Regardless of your situation, it is understandable that you likely feel uneasiness due to the recall if you have been using a Philips breathing machine that was affected. Remember, currently, it is difficult to understand exactly how many people will be impacted by this potential health risk. As a result, while the recall presents a reason for concern, you should do everything that you can to avoid panicking over the situation. You should also realize that speaking to your physician about the recall is critical if you have noticed either degradation or erosion of the foam components in your CPAP machine, you have begun experiencing health conditions that you think are connected to a recalled machine or to be screened for any one of the types of cancer known to result from exposure to the particles and gases created by the foam.
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The Company’s Plan for Remedying the Defect
The company has stated that it will replace its current sound abatement foam with new material and has already begun preparations, such as obtaining the necessary regulatory approval. The company has stated that it is focused on resolving the issue as quickly as possible. As part of its efforts, Philip’s first-generation DreamStation will be modified with a different sound abatement foam and shipped following receipt of the necessary clearances. The company’s more recent, DreamStation 2, is not affected by this recall.
Speak with a Defective Product Attorney
If you have been diagnosed with cancer and wonder whether your Philips CPAP machine played a role in causing your illness, you should not hesitate to speak with a knowledgeable Long Island product liability attorney immediately. Contact the Law Office of Cohen & Jaffe LLP today to schedule your free case evaluation.