FDA Receives 21,000 Reports About Philips CPAP Issues

FDA Receives 21,000 Reports About Philips CPAP Issues

Introduction

The recalled sleep apnea devices face more than 21,000 reports against it, including at least 124 deaths, claiming that the devices release small particles which are harmful and might cause cancer.

Last year Philips recalled all the sleep apnea machines sold between 2009 and April 2021 as the users claimed that the devices are faulty and contained a defective polyester-based polyurethane (PE-PUR) sound abatement foam.

The foam of the machines is designed to reduce noise and vibrations while sleeping. The users discovered that the foam degrades and breaks down over time and releases toxic particles and debris into the machine's pathways, CPAP mask and ultimately in the lungs of the users.

Currently, Philips CPAP faces hundreds of lawsuits from its former users alleging that the regular use of the machines resulted in causing lung damage, respiratory injuries and various types of cancer. It is also estimated that the company will face additional claims in the coming months and years.

Earlier this week, the U.S. Food and Drug Administration (FDA) identified numerous problems with the Philips CPAP machines. The agency identified that the court received more than 21,000 reports of the Philips CPAP from the users between April 2021 and April 30, 2022. The reports state that the defects in the machine resulted in 124 deaths and also involve the risk of cancer, pneumonia, asthma, infections, headaches, coughs, breathing problems, dizziness, chest pains and other side effects.

The sudden spike in the reports is a matter of concern for the manufacturer of CPAP machines, as earlier between 2011 and April 2021, the agency only received 30 reports, from which eight were submitted from the U.S.

FDA warns that the analysis and reports of the devices should not be considered an accurate representation of the various problems associated with the machines as this passive surveillance system has limitations. The agency will continue its efforts to review and assess the reports. It will soon provide more updates about the machines as soon as new information is revealed.

As per an inspection report provided by the FDA, Philips was aware about the problem of degrading sound abatement foam since 2015, and it was evident in the emails exchanged with the foam supplier. However, the machines did not face any corrective actions or investigation until the recall was announced in June 2021.