Nov 29, 2023
Philips statement on recent FDA safety notification related to DreamStation 2
Philips Respironics’ number one priority is patient safety and quality. Philips Respironics is in discussions with the U.S. Food and Drug Administration (FDA) regarding the reports it filed with the FDA related to possible thermal issues in the humidifier of the DreamStation 2 sleep therapy device while in use.
Philips Respironics filed these approximately 270 reports over the last three months which cover a three-year period following a retrospective review of possible thermal complaints related to DreamStation 2 since the launch of the product.
The FDA has issued a safety communication on this matter: Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication | FDA.
Philips Respironics conducted a review and analysis regarding reports of the possible thermal issues in accordance with its regulatory processes. The devices can continue to be used provided that the safety instructions in the instructions for use for the DreamStation 2 sleep therapy device are followed.
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2022 sales of EUR 17.8 billion and employs approximately 70,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
