Looking for representation? Our experience, expertise, and resources make Hollis Law the ideal partner.
On June 14, 2021, Philips Respironics issued a voluntary recall on multiple positive airway pressure devices due to possible health risks.
Continuous positive airway pressures (CPAP) and Bi-Level Positive Airway Pressure (Bi-Level PAP) are respiratory ventilation devices used for people who suffer from obstructive sleep apnea. Obstructive sleep apnea is a sleep breathing disorder that causes either complete or partial obstruction of a person’s upper airway while asleep.
Invented in 1981 by Australian Doctor Colin Sullivan, the CPAP machine was born out of Dr. Sullivan’s long-term interest in the upper respiratory airway of humans and its relation to grave medical episodes like sudden infant death syndrome. Only being able to test his CPAP prototypes on dogs such as pugs, bulldogs, boxers; Dr. Sullivan would have his eureka moment when the ideal patient came to his respiratory lab with all the serious hallmarks of sleep apnea. Initially, Dr. Sullivan recommended a tracheotomy because of the severeness of the patients’ sleep apnea. However, the patient declined to go forward with the procedure and decided to submit to Dr. Sullivan’s continuous air pressure experiment. After 7 hours of monitored sleep by Dr. Sullivan, upon waking up, the patient felt more alert for the first time in years after using Dr. Sullivan’s CPAP prototype while asleep.
This experiment would springboard not only the efficacy of Dr. Sullivan’s CPAP prototype in terms of scaling the prototype to be sold on the market but also further research into obstructive sleep apnea and the problems that are caused from it in humans. By the mid-1980s, Phillips Respironics brought to market the first suitable CPAP machine in the United States.
On April 26, 2021, Philips Respironics publicly announced that they were analyzing health risks related to sound abatement foam used in their CPAP, Bi-level PAP, and mechanical ventilators out of an abundance of caution. After further analysis, on June 14, 2021, Philips Respironics issued a voluntary recall on multiple positive airway pressure devices for a few reasons. Their June 14th announcement states that possible health risks from their PAP machines includes exposure to degraded sound abatement foam which is caused by unapproved cleaning products like ozone-related cleaning products and chemical emissions exposure from the foam material. Furthermore, their announcement states high temperature and very humid regions can contribute to the sound abatement foam degradation.
What does the sound abatement foam degradation entail?
The sound abatement foam is a polyester-based polyurethane (PE-PUR) foam that is designed to quiet the sound emitted from the positive airway pressure device. Because of the improper cleaning techniques and high temperature and high humid regions, the PE-PUR foam can decompose into particles that can enter the devices air pathway that would either be ingested or inhaled by the PAP user.
Exposure to the degraded PE-PUR foam either through ingestion or inhalation can cause headaches, irritation, inflammation, respiratory problems, and possible carcinogenic effects. As of now there have been no deaths reported in connection to this recall. In addition to the sound abatement foam degradation, some Philips PAP users have reported to find black debris in the devices breathing tubes which can also cause breathing problems, headache, inflammation, irritation, nausea and other possible toxic effects.
Recalled Phillips Respironics devices
CPAP and BiLevel PAP
- Continuous Ventilator, Non-life supporting
- DreamStation ASV
- DreamStation ST, AVAPS
- C Series ASV, S/T, AVAPS
- OmniLab Advanced Plus In-Lab Titration Device
- SystemOne ASV4
- Non-continuous Ventilator
- DreamStation CPAP, Auto CPAP, BIPAP
- DreamStation Go CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Auto CPAP
- Continuous Ventilator, Minimum Ventilatory Support, Facility USe
- E30 (Under Emergency Use Authorization)
- Continuous Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- A-Series BiPAP V30 Auto Ventilator