Out of an abundance of caution and based on the latest available information, Philips issued a field safety notice on June 14, 2021 in connection with potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.
In consultation with relevant regulatory agencies, Philips has refined the field safety notice for specific countries in Europe.
The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam,for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.
At the time of the June 2021 field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions. Philips continues to monitor complaints received following the field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve.