Updated Philips DreamStation 2 FDA Safety Communication - Here’s What We Know

We were recently notified of a product update regarding the Philips Respironics DreamStation 2. On November 28th, the FDA issued a safety communication for the DreamStation 2, citing reports that some devices had shown signs of overheating.

At CPAP.com, we understand that you may be frustrated and concerned, especially after all that you’ve been through during the 2021 Philips Recall. We understand that these updates have an impact on all of the relationships we value - our loved ones, friends, colleagues, and customers. We empathize with the challenges that come with this news and assure you that we are here to support you and offer assistance where we can.

We are hearing a lot of confusion surrounding this latest notice from the FDA. But we want to make one point very clear: this is NOT a recall of the DreamStation 2 CPAP Machine.

In this article, we will discuss:

• Known FDA Reports and Incidents
• What Philips Respironics Has Said
• Facts About The Reports
• Actionable Steps You Can Take Next
• What CPAP.com Is Doing

We recommend bookmarking this article as we will keep it updated with any new information regarding changes made by the FDA or Philips to the DreamStation 2 device.

These reports included incidents involving one or more of the following:

• Incidents of overheating, such as fire, smoke, and burns have been reported
• The FDA indicates that “the thermal issues reported for the DreamStation 2 CPAP machines may be related to an electrical or a mechanical malfunction of the machine, which may cause it to overheat in certain situations.”

“The FDA issued a safety communication to inform the public of reports involving thermal issues with the [DreamStation 2] machine, some of which cited patient injuries, and to provide safety recommendations for patient use, including carefully monitoring machines for signs of overheating.”

You can read the FDA’s full statement here.

Philips Respironics has confirmed to us and their customers that they are fully cooperating with the investigation. They also believe they may know the reason for this sudden spike in safety reports.

“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.”

We understand that this report may be highly concerning to you, especially if you were impacted by the original Philips Respironics Recall. We want to take a moment to provide you with the facts of the situation, plus some safety tips you can follow to protect yourself and your equipment.

While the FDA has issued a safety warning for the DreamStation 2, they have NOT ordered a machine recall. A recall will only take place if the upcoming investigation finds that these events were caused by device malfunction.

According to the FDA, this initial safety warning was released following reports of the device overheating. These reports will now be investigated fully to ensure they were not caused by device malfunction.

The FDA has NOT asked customers to stop using their DreamStation 2 devices at this time. However, they have encouraged people to practice common safety practices outlined in the DreamStation 2 Owners Manual.

According to both the FDA and Philips Respironics, the company is fully cooperating. They will continue to assist with ongoing investigations until a conclusion has been made regarding the cause of these thermal incidents.

The FDA states reports of DreamStation 2 overheating are not related to the previous recall, which involved devices that used a material called PE-PUR foam. The DreamStation 2 has never used that type of foam and was not part of the 2021 recall.

So far, this is only a safety warning. The FDA has not asked DreamStation 2 owners to stop using their devices. However, there are a few things you can do to minimize any risks to you or your device.

• Be sure to follow the manufacturer’s instructions carefully.
• Keep your CPAP machine away from flammable materials, including carpet, paper, and towels.
• Place the device on a hard, flat surface.
• Clean your CPAP machine on time each week.
• Allow your CPAP machine to cool off for at least 15 minutes before emptying the water tank after each use.
• Unplug your CPAP when it isn’t being used.
• Keep an eye out for signs of overheating, including any unusual smells, sounds, or changes in the appearance of your DreamStation 2.

You deserve to feel safe and confident while using your CPAP machine. We promise to continue closely monitoring the situation and will provide you with updates as we receive them.

Should the FDA or Philips Respironics announce further guidance for using the DreamStation 2, we will let you know via email and in this blog article.

Thank you for your continued trust in CPAP.com, and if you have any questions or are considering switching from the DreamStation 2, we are here to serve you.

Sincerely,

The CPAP.com Team

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