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Medical Device Field safety notice (Outside of U.S.)

Medical Device
Field Safety Notice (Outside of U.S.)

Philips Respironics

There is nothing we take more seriously than providing patients with high quality products that are safe and reliable. If an issue arises, we are proactive in communicating and addressing it as we work tirelessly towards a resolution.

On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.


At that time, out of an abundance of caution and based on available information, Philips advised of 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. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.


As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.


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 recall / 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 recall / field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve.

The notification advises patients and customers to take the following actions:

 

  • For patients using BiLevel PAP and CPAP devices:
    Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
  • For patients using life-sustaining mechanical ventilator devices:
    DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.


Philips is recommending that customers and patients do not use ozone-related cleaning products. 


Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.

We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. 


The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. 


For more information on the recall notification (U.S. only) / field safety notice (Outside of U.S.), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update.