In June 2021, Philips Respironics issued a recall of over 15 million CPAP and BiPAP machines and ventilators due to the presence of black debris in the device’s air pathway that was causing adverse health problems to users. This led Philips to determine that the PE-PUR sound abatement form used to minimize noise in its machines could break down and cause users to inhale or swallow the foam particles and chemical emissions.
But what did the maker of recalled CPAP machines know, and when? Based on company records, Philips employees were concerned about the integrity of the foam years before the recall was issued.
Since Philips initiated the recall over two years ago, the U.S. Food and Drug Administration (FDA) has received over 105,000 medical device reports associated with the degraded or suspected degradation of the PE-PUR foam. The reports include adverse events, including cancer, pneumonia, asthma, infection, and other respiratory problems, as well as 385 deaths.
What Did Philips Respironics Know About the Recalled CPAP Machines?
Philips announced the recall of millions of CPAP and BiPAP Machines and ventilators in June 2021. The initial recall involved 20 different types of breathing machines manufactured before April 26, 2021. The company said that the issues “can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” At that point, Philips said it had received reports of headache, upper airway irritation, cough, chest pressure, and serious infection.
Philips further cautioned that potential risks of particle exposure include:
- Skin, eye, and respiratory tract irritation
- Inflammatory response
- Adverse effects to other organs (kidneys, liver)
- Toxic carcinogenic effects
The foam was also prone to releasing chemicals as a vapor into the air, a process known as off-gassing. The potential risks of chemical exposure to off-gassing include:
- Eye, nose, respiratory tract, skin irritation
- Toxic and carcinogenic effects
The FDA issued a Safety Communication announcing that it was analyzing medical device reports from 2009 to 2021 for issues that could be related to the PE-PUR foam degradation issue. The agency classified the recall as a Class I, the most serious type of recall. This means there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
So, how long before the recall did Philips know about the CPAP defect? In a Q1 2021 quarterly report filed on April 26. 2021, Philips disclosed for the first time that users of its sleep apnea devices had reported adverse health effects after using the machines. Those reports led to the discovery that the sound abatement form could break down into black debris within the devices’ air pathways. The company announced the recall nearly two months later.
But an internal email between a Philips employee and a foam supplier dating back to 2015, specifically discusses the sound abatement foam degradation issues.
What CPAP Machine Was Recalled?
The CPAP recall involves the following ventilators and CPAP and BiPAP machines:
- Trilogy 100
- Trilogy 200
- Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
- A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
- A-Series BiPAP A40
- A-Series BiPAP A30
CPAP and BiPAP Devices
Continuous, Minimum Ventilatory Support, Facility Use
- E30 (Emergency Use Authorization)
Continuous, Non-Life Supporting
- SystemOne ASV4
- C-series ASV
- C-Series S.T and AVAPS
- DreamStation ASV
- DreamStation ST, AVAPS
- OmniLab Advanced+
- Dorma 400
- Dorma 500
- REMstar SE Auto
- SystemOne (Q-Series)
- DreamStation Go
Philips Respironics also recalled previously recalled, reworked, and reissued Trilogy 100 and Trilogy 200 ventilators. The recall was issued after the company discovered issues with the silicone sound abatement foam used to replace the defective PE-PUR foam separating from the plastic backing and posing a risk of airway blockage. Some reworked machines were also found with residual PE-PUR sound abatement foam.
Harmed by a Recalled Philips CPAP Machine? Contact an Experienced Lawyer Today
If a defective CPAP machine has injured you or someone you love, it is important to seek legal help right away. An attorney can help you understand your legal options and fight for the compensation you deserve.
The mass tort lawyers at Lawsuit Legal News have years of experience helping people like you seek the compensation they deserve from the companies who harmed them. Contact us today at 866-467-0943 or complete our online contact form for a free case consultation.