Is the DreamStation 2 CPAP catching fire? Another Recall?

  • By Clay Rollyson
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There has been a lot of talk lately about the DreamSation 2 CPAP from Philips Respironics, and potential issues. Some have even said that there will be another recall. Much of this is due to reported “thermal events” from DreamStation 2 CPAP users. In this blog we are going to expand on what “thermal events” mean, as well as the details of reported DreamStation 2 issues.

DreamStation 2 CPAP Thermal Events:

A thermal event is defined as anything related to the heated humidifier portion of the DreamStation 2 CPAP. Some reports have indicated that the user experienced the heater getting really hot. Others have reported that they smelled burning plastic or something getting hot. These cases are filed with the FDA by Philips Respironics as they are required to do.

How Many Thermal Events have been filed with the FDA?

Since the DreamStation 2 was launched there have been Millions distributed worldwide. Out of that total number there have been about 270 thermal events documented and reported to the FDA by Philips Respironics. That number is accurate as of the date this blog is published. These were reported in batches that may have created a bit of a concern, because it looked like a quick uptick in these vents.

Have DreamStation 2 CPAPs caught on fire?

The words “thermal event” definitely causes significant concern. For some reason it causes me to think of a nuclear bomb. Not exactly what you want people to think about their CPAP machine. However, according to Respironics, not a single DreamStation 2 CPAP has caught on fire. Of course, my reference on this is Philips Respironics, but with the level of scrutiny that they are under from the FDA, it seems unlikely that they would not be misleading anyone right now.

What is Philips Respironics saying about these concerns?

On November 28, the U.S. Food and Drug Administration (FDA) released a safety communication regarding possible thermal issues with the DreamStation 2 sleep therapy device while in use. There was not a sharp increase of reportable complaints. As part of our ongoing commitment to patient safety and quality, we conducted a retrospective review of possible DreamStation 2 thermal complaints initiated over the course of an almost three-year period since its launch in 2021. We filed approximately 270 reports with the FDA over the last three months as part of this post market surveillance. These reports were submitted in batches starting in August 2023, which we believe may have been interpreted incorrectly as a sharp increase in customer complaints. DreamStation 2 can continue to be used. As with any medical device, the instructions for use should be followed. Our number one priority continues to be patient safety and quality and we treat all feedback from our patients and our regulators with the highest levels of urgency. It is important to note:
  • Outside of continued adherence to the instructions for use, no additional action is needed by patients or DME/homecare providers as a result of the FDA’s publication.
  • There is no product recall at this time.

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