[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[StratCat48]

I have seen here and elsewhere claims that the replacements are themselves not safe.
Is there any consensus on this thread about if the replacement machines are safe to use or not?

My 2 cents worth..........

I've been using a replacement Dream Station 2 since Oct 2021 with no issues. I'm inclined to believe the reports of overheating or burning users may be users mostly not reading/adhering to instructions in the manual.

The water tank heating plate that extends from the DS2 does get hot when in use and should not be placed on anything that could possibly impede air flow under it or is potentially flammable. (I have more trust in a DS2 not burning down my house than I would charging an EV in my garage)
"Do not place the device directly onto carpet, fabric, or other flammable materials."

Yup, the heater plate can be hot for a short while after the machine is used.......
"Allow the heater plate and water to cool down for approximately 15 minutes before removing the humidifier water tank. A burn may result from: touching the heater plate, coming in contact with the heated water, or touching the humidifier water tank pan."

Regarding the report of formaldehyde, it's a chemical component found in many foams and many other products that are produced. Most furniture, car upholstery and trim (part of the new car smell) and some wood products (waferboard for example used in house construction) all outgas formaldehyde to varying degrees. I wonder if there have ever been tests on other CPAP manufacturers components that are used in their CPAP's. Philips/Respironics is under the microscope from issues with the DS1, so it's of no surprise that something else was found. I'm not sure I ever saw anywhere that the DS2 foam exceeded any formaldehyde limits that would be harmful, the reports simply stated it was 'found' in testing from what I had seen.

[Sleeprider]

Sheepish, the replacement foam seems the best of two evils to me. Fortunately I don't have to make that choice. I last used a Philips System One machine back in 2015 and when I got the Resmed, I never looked back.

[TechieHippie]

This is a little off-topic, but do we know anything about how Resmed foam stacks up?

[btreger]

yahoo/news

Reuters

US FDA says 561 deaths related to Philips machines since 2021

The U.S. Food and Drug Administration said on Wednesday there have been 561 deaths reported since 2021 related to the use of Philips' recalled ventilators and machines for treating obstructive sleep apnea.

The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.

US FDA says 561 deaths related to Philips machines since 2021 (yahoo.com)

[Sheepish]

When I inquired, I was told the replacement machine would have a manufacturing date of September 2023, but when I went to pick it up just now, it has a manufacturing date of April 2023.



If used, am I good to go, or am I a goner?  

[Sleeprider]

Ask yourself why Canadians are required to accept a device that cannot be sold in the U.S. in accordance with a FDA consent decree. You guys are too good at just kindly taking whatever your socialist state throws at you. https://www.apneaboard.com/forums/Thread...op-selling

All the Philips devices are on trucks heading to Canada, because your provincial health services will still sell them and call it a cost savings for the people.

[Sheepish]

Sleeprider

All these machines not being sold in the U.S. are probably on an express truck to Canada. 

Ask yourself why Canadians are required to accept a device that cannot be sold in the U.S. in accordance with a FDA consent decree.  You guys are too good at just kindly taking whatever your socialist state throws at you.  https://www.apneaboard.com/forums/Thread...op-selling

All the Philips devices are on trucks heading to Canada, because your provincial health services will still sell them and call it a cost savings for the people.

Health Canada, the Canadian counterpart to the FDA, is basically a guy in a cubicle with a high-speed internet connection to the FDA, and whose skillset boils down to dexterous mastery of the keyboard shortcuts Ctrl+C and Ctrl+V.

For the record, in Quebec anyhow, xPAP machines aren't even covered by gov't. health insurance, so you have to pay out of pocket. 

That said, in terms of even allowing these machines to continue to be distributed here, perhaps the internet is down in Health Canada's cubicle.

Sheepish, the replacement foam seems the best of two evils to me.  Fortunately I don't have to make that choice.  I last used a Philips System One machine back in 2015 and when I got the Resmed, I never looked back.

I'm currently using a ResMed AirSense Elite a good friend who never used it has lent me. It's not what I'd call "elite" since it's not an APAP, but a fixed-pressure brick. Nonetheless, with clinician's settings for titration and tinkering, the EPR at 2, and humidity and temperature tweaks, I'm making it work to my satisfaction. AHI is usually between 1 and 2 and it's comfortable. 

My only kvetch is that the water tank can be a bit more of a pain to pull out by force and fill than the easy DreamStation 1 water tank.

[btreger]

DreamStation Go

There seems to be some confusion regarding this device:

I will attempt to clear some of that up.

1st:

There was a Remediation e-mail sent to registered owners of this device on 07/05/23

2nd:

There was a packet sent out to all registered owners, "Class Action Settlement" In early January 2024

This is the Remediation e-mail:

Philips Respironics DreamStation Go Remediation

We’re reaching out to you because you have registered a Philips Respironics DreamStation Go CPAP device in response to the voluntary recall of certain CPAP, BiPAP, and mechanical ventilator devices.

Two options for remediation are now available to you.

You must select one of the following two options below in the Patient Portal. There is no default option and in the absence of your selection, no action can be taken. If you have retained a lawyer, you may wish to consult with them before making your decisions.

Please sign into the Patient Portal to select your preferred option:

OPTION 1 - Financial payment for return of affected units: You can select the financial payment option in the Patient Portal to receive $500, based on the manufacturing date of your affected device. The payment that we are offering is to help ensure that affected units are no longer in use. You will receive this payment via check when we receive your affected DreamStation Go device. Philips Respironics will cover the packaging and return costs once you have taken your device to a FedEx location. Please note return instructions will be included in the Patient Portal once you select this option.

OPTION 2 – Elect to receive a replacement device: If you elect to remain in the remediation course, you must make the selection in the Patient Portal. You may need to provide a current prescription and will be notified in the Patient Portal if that is the case. If you are unable, for any reason, to provide us with your current device therapy prescription, you have the option to receive a replacement device with automatic adjusted settings more commonly known as Auto-adjusting CPAP. You can learn more about Auto-adjusting CPAP settings here.

Regardless of which option you select, we encourage you to consult with your physician about options for a new device to ensure continuity of care. Since your physician knows your medical history, they are most qualified to discuss your therapy options.

If your shipping address has changed since you registered your affected device, you would like to make your election over the phone, or if you have any questions, please call 877-907-7508.

Thank you for your continued patience and trust.

Note: There is no Go replacement device, only a DS1 or DS2. As I stated earlier I chose Option 1, and I printed out my return label from the portal. I took my device and label, to my closest UPS store and paid $7 to have them ship it out. I checked the status of the shipment until it arrived and was signed for. In roughly 3 weeks I received a check for $500, which I had previously posted.

[Gideon]

Sheepish

I do not consider the ResMed AirSense 10 a brick since it has comprehensive data on which you can determine an optimal therapy for that machine. I do prefer the AutoSet s for their ability to react to events though this does not work for everyone.

[btreger]

Philips Class Action Settlement Packet

I have yet to see any conversations on this subject.

Like the Recall itself, many questions came out from people not quite sure how to fill those documents out.

I have filled mine out and submitted it. I received a confirmation back from Philips within five minutes.

So, if there is any interest I would be glad to share what I learned. What documents do you need before starting etc?

I can only tell you how I filled mine out. I cannot tell you how to fill yours out. There are too many options. 

Note: I am asking Philips for a Device Replacement Award