Health Issues May Have Been Known Years Before Recalling CPAP Machines

 Posted on December 13, 2021 in Uncategorized

CPAP machines provide effective treatment for people who have been diagnosed with sleep apnea. However, many of the users of these devices may have been placed at risk of injuries or illnesses. In 2021, the medical device manufacturer Philips Respironics issued a recall of millions of CPAP and BiPAP devices. This recall was performed because the devices contained a noise-dampening foam that could break down, putting users at risk of harm when they inhaled tiny particles and toxic chemicals. This recall has caused difficulty for many users who have had to decide whether to continue using potentially harmful devices or go without treatment for sleep apnea or other conditions until replacement devices are available. Many people are also troubled by recent findings that Philips may have known about the issue for years before deciding to perform a recall.

FDA Investigation Uncovers Details Showing that Philips May Have Known About Health Risks to CPAP and BiPAP Users

In response to the voluntary recall performed by Philips, the U.S. Food and Drug Administration (FDA) has been investigating the manufacturer’s facilities and records, and it has uncovered some troubling details. The FDA evaluated these records to gain a better understanding of the causes of the health risks and determine whether the correct procedures were used during the design and manufacturing process. The FDA found that at least 14 tests or assessments had been performed since 2016 that indicated that there were concerns about the degradation of the foam used in CPAP and BiPAP devices. 

Internal emails at the company also indicated that Phillips understood the problems with their devices but did not take action to correct the issue. Emails from company employees to a foam supplier dating back to 2015 implied that Phillips had been made aware of the issues with foam degradation. Emails with inspectors from 2018 also found that internal tests at the company had discovered the problem, but Philips decided not to change the design of their devices at this time.

The company had also received numerous complaints from consumers that should have raised concerns about health risks. Since 2008, more than 220,000 complaints were received containing keywords such as “foam, particles, debris, and airway.” Between 2014 and 2017, at least 110 of these complaints were directly related to the issues with foam degradation. Despite all of these warnings, Phillips waited until 2021 to perform a recall, allowing people to continue using devices that were known to cause potential health risks.

Contact Our CPAP Recall Lawyers

The details uncovered by the FDA seem to show that Phillips has put its profits ahead of people’s health because it did not take action to address the serious risks faced by the users of its devices. Those who have used the recalled devices may be able to take legal action to address the company’s failure to protect their health and safety. If you have used one of the recalled CPAP or BiPAP machines, contact our CPAP injury attorneys to arrange a free consultation and learn more about your legal options.

Sources:

https://www.nbcchicago.com/consumer/fda-finds-maker-of-recalled-sleep-aid-devices-knew-of-problems-for-years-but-didnt-act/2698459/

https://www.fda.gov/news-events/press-announcements/fda-provides-update-recall-certain-philips-respironics-breathing-assistance-machines