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cpap injury lawyerCPAP 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.

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