Philips CPAP and BiPAP Breathing Machines Recalled Over Risk of Lung Injury
Philips Respironics has recalled millions of its breathing machines due to a potential risk of lung injury. The recall includes certain models of Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices whose polyester-based polyurethane foam liners may disintegrate or outgas.
Use of the recalled devices may have resulted in inhalation of contaminants and/or toxic chemicals, increasing the chance for serious lung injury, risk of cancer or death.
Over 21,000 adverse events caused by the affected Philips CPAP and BiPAP sleep apnea machines have been reported to the U.S. Food and Drug Administration, including at least 124 deaths. The company may be facing thousands of lawsuits filed by people or loved ones of those who were injured by a Philips sleep apnea CPAP, BiPAP or mechanical ventilator device.
Philips estimates that up to 4 million devices may be affected by the PE-PUR related recall and has limited the recall to the U.S. market.
Recalled Philips Devices Include:
CPAP and BiLevel PAP
Continuous Ventilator, Non-life Supporting
- C Series ASV, S/T, AVAPS
- DreamStation ASV
- DreamStation ST, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne ASV4
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation Go CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- SystemOne Q series
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Trilogy Evo Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP V30 Auto Ventilator
- E30 (Under Emergency Use Authorization)
- Trilogy Evo repair kit
FDA Upgrades Philips CPAP Recall to Class 1
In April of 2021, Philips Respironics issued a voluntary recall for some of their CPAP and BiPAP ventilator devices used for sleep apnea. The recall was issued due to possible degradation of the polyester-based polyurethane (PE-PUR) foam sound-abatement liner which may degrade to release particles and chemicals that may be inhaled.
In June 2021, the FDA upgraded the recall to a “Class I” designation which indicates that failure or malfunction of the device may result in serious injury or death. Additional ventilators and ventilator repair kits were added to the recall list in January 2022. Up to four million individual devices are included in the recall, most of which are from the DreamStation, first-generation production line and are within the 5-year service life.
PE-PUR Sound-Abatement Foam Liner Responsible for Recall
The June 2021 voluntary Philips Respironics CPAP and ventilator recall was issued due to a possibility of increased risk of airway contamination or inhalation of particles or chemicals released due to degradation of a polyester-based polyurethane foam liner intended to reduce noise of the device. The recall was later upgraded to an FDA Class 1 recall, due to serious risk of injury or death. Thousands of serious injuries have been reported to the FDA, including over 124 deaths.
The PE-PUR foam liner used in affected devices may degrade into particles, traveling through the device air pathway, to be inhaled or ingested. The foam may also be prone to “out-gas” degradation chemicals that may be toxic. Though most of the devices are still within the service period, those that are greater than three years old are more likely to have degraded foam.
Philips Failed to Act Degrading Foam in CPAP Devices
Internal documents show that Philips may have known about the potential for foam degradation in their breathing devices since 2015. Discovery documents show that in April of 2018, an engineer for Philips contacted the foam supplier over concerns of degradation. In addition, emails and communications show that multiple instances of foam degradation and shedding, with the potential for inhalation of particles was not acted on by the company.
Philips has claimed that possibility of degradation and fume outgassing may be worsened when unapproved cleaning methods such as high-heat, high humidity and ozone are used. Ozone cleaning companies, such as SoClean, have disputed claims that their methods are to blame. SoClean filed lawsuit against Philips for making false and misleading statements and accusations, later amending the complaint to include FDA inspection information which showed that Philips was aware of the potential for degradation of the PE-PUR foam.
FDA Expresses Concerns with Philips Recalls and Recommendations
As part of the recall, users of the Philips CPAP, BiPAP non-life supporting devices were advised to discontinue use until the units could be repaired or replaced. Those using life-supporting ventilators were advised not to discontinue the devices until medical assistance had been obtained.
Philips announced approval of a plan to repair or replace the foam liners or devices in September 2021. On November 12, 2021, just 10 weeks later, the FDA announced another recall, this time of the silicone foam which had been used in replacement devices. In addition, several types of repair kits were added to the recall in January of 2022.
The FDA has expressed concerns that the problems may still be larger and more severe than has been represented by Philips. Some of the testing for the devices may have only been conducted on new machines, when many of the CPAP and BiPAP units are sold as “refurbished” devices. Refurbished units may be potentially subject to more degradation and the lack of testing to confirm safety is concerning.
In September 2022, Philips also issued another recall for some of its BiPAP devices which may contain a plastic contaminated with volatile organic compounds (VOCs). Though this is not part of the same recall, it may have affected some of the same devices.
Philips PE-PUR CPAP Foam Liner Degradation Health Risks
Polyester-based polyurethane is petroleum product that may be made into sound-abatement foam liners used in Philips CPAP, BiPAP and ventilator devices. Over time, it may degrade to release particles and plastic dust and may outgas a plastics-based vapor which contains toxic chemicals that may be harmful.
Symptoms of PE-PUR exposure may include:
- Throat or mucous membrane irritation
- Sinus infection
- Lung inflammation
- Chest pressure
- Nausea and vomiting
Symptoms of PE-PUR exposure should be reported to a medical practitioner right away. Facilities or caregivers of people who using a life-supporting ventilator should not discontinue using the ventilator but should seek immediate medical attention.
Philips Respironics CPAP Lung Injury Lawsuit
Philips Respironics may be facing thousands of CPAP and BiPAP lung injury lawsuits due to injuries and deaths caused by degradation of the foam liners in the breathing machines. Hundreds of Philips CPAP Recall Lawsuits have already been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Western District of Pennsylvania. People or loved ones of those who used or suffered injury or death after using a Philips CPAP, BiPAP or ventilator device, may be eligible for compensation.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.