FDA Issues Alert on Safety Concerns with Certain CPAP Machines

Reports of thermal issues with Philips DreamStation 2 CPAP Machines prompt discussions with the company.

The U.S. Food and Drug Administration (FDA) has alerted patients and healthcare providers about a safety concern associated with Philips Respironics’ DreamStation 2 Continuous Positive Airway Pressure (CPAP) machines used for treating obstructive sleep apnea. In response to the medical device reports indicating thermal issues, including instances of patient injuries, the FDA issued safety recommendations for users. The reports also revealed incidents such as fires, smoke, burns, and signs of overheating during machine use, prompting discussions with Philips Respironics on mitigation strategies.

“We will continue to monitor the company’s handling of this, among other safety issues, to ensure they take appropriate steps to mitigate the risk to patients,” said FDA’s Center for Devices and Radiological Health Director Jeff Shuren. “We share the public’s concerns regarding the new and continued safety issues of CPAP machines and certain recalled medical devices manufactured by Philips.”

The FDA became aware of the issue during a routine analysis of reports, noting a significant increase related to thermal issues between August 1 and November 15 of this year.

As the Lord Leads, Pray with Us…

  • For Director Shuren as he oversees the Center for Devices and Radiological Health.
  • For Commissioner Califf as he heads the Food and Drug Administration.
  • For FDA officials as they perform routine analysis of medical incident and device reports.

Sources: Food and Drug Administration

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