More Than 69,000 CPAP Adverse Event Reports Submitted to FDA Since 2021

Over the past 16 months, the U.S. Food and Drug Administration (FDA) has received more than 69,000 medical device reports (MDRs) detailing adverse events associated with recalled Philips CPAP, BiPAP, and ventilator machines, including 168 reports of death. The MDRs have to do with the breakdown or suspected breakdown of PE-PUR foam, which led to a recall in June 2021 and has been linked to a possible increased risk of cancer and other serious health complications. If you or someone you love has suffered an adverse event you believed to be related to defective foam used in a recalled Philips CPAP, BiPAP, or ventilator device, contact Robert Brown Law today. We have extensive experience handling defective product injury claims, and we can help you and your family fight to recover the compensation you are entitled to for your injuries.

Philips CPAP Recall Information

On June 30, 2021, the FDA announced a recall of certain continuous positive airway pressure (CPAP) machines, bilevel positive airway pressure (BiPAP) machines, and continuous ventilators manufactured by Philips Respironics between 2009 and April 26, 2021. “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway,” the FDA stated in the safety communication. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.” The breakdown of the foam and potential inhalation or ingestion of the resulting debris or chemicals can cause serious injury, the FDA warns, and these injuries “can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.”

Over the past 16 months, the U.S. Food and Drug Administration (FDA) has received more than 69,000 medical device reports (MDRs) detailing adverse events associated with recalled Philips CPAP, BiPAP, and ventilator machines, including 168 reports of death.

Side Effects Potentially Linked to PE-PUR Foam Breakdown

The FDA on August 16, 2022, updated the initial Philips CPAP safety communication to provide the latest information about medical device reports (MDRs) related to the device recall and associated adverse events. As the FDA notes on the updated CPAP recall page, “Manufacturers, such as Philips, are required to submit MDRs when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”

Between 2011 and April 2021, Philips submitted only 30 MDRs that the company identified as being linked to the PE-PUR foam breakdown. However, reports of device malfunctions and adverse events can also be submitted to the FDA by healthcare professionals, patients, and consumers, and since April 2021, the FDA has reportedly received more than 69,000 MDRs associated with PE-PUR foam breakdown or suspected breakdown in Philips CPAP, BiPAP, and ventilator machines, including 168 reports of patient death. More than 48,000 of these MDRs, including 44 reports of death, were submitted to the FDA over the course of just three months, from May 1, 2022, through July 31, 2022. These MDRs have included a wide range of injuries, including:

• Cancer
• Pneumonia
• Asthma
• Respiratory problems
• Headache
• Cough
• Infection
• Difficulty breathing
• Dizziness
• Chest pain
• Nodules

Contact Robert Brown Law Today for Qualified Legal Help

It can be scary to suffer injuries from a defective medical device, and for many, the thought of going toe to toe with a major medical device manufacturer while seeking treatment for your injuries may seem daunting. When you choose our knowledgeable product liability attorneys at Robert Brown Law, we will stand by your side every step of the way and fight tirelessly for your rights, so you can focus on your recovery.