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

[GWild]

Lol - in that not-so-funny way. I have two System One's - a 550 and a 560. I had replacing the 560 with a Dreamstation on my agenda - but kept putting it off because I didn't want to deal with insurance and re-experience the DME hell. Looks like I got lucky there.

Now it seems I'll be taking my 560 apart tonight to see just how bad my foam is. By the looks of the tear down video, there is a lot of foam surface area in contact with the airflow. I've had unexplained hoarseness these past couple years and diminished lung performance (5 year old machine).

Except that the foam particles are being blown into the lungs under pressure, this probably isn't much worse than living with 5 year old poly carpet under foot with kids, pets, people shuffling around and stirring up that dust, or the carbon dust from all the tires on the road kicking up in front of you on the freeway every day.

Sigh ... also pretty sure I am sol with any compensation - my machines are probably EOL or worse and outside the replacement window. Then again - I'll be certain to join any class action if they don't offer up something.

ps: I have my two machines registered... we'll see what happens.

[Zalagar]

Can you explain why you had to get a new sleep study? You own the machine after 5 years, and your doctor gets the reports of your daily use. Is it an insurance issue or a pass the buck situation.

Yeah, in order for my insurance to cover a new machine, they require you to have owned your current machine for atleast 5 years and to get a new current Sleep Study to prove you still have sleep apnea. So at the moment, my doctor can't even put in a prescription for a new machine yet.  I can't afford out of pocket funding for a new machine, so I have to jump through the hoops for the insurance company.

[RayBee]

What is the name of your insurance company? I’m in CA and have many friends with sleep apnea too. It would be nice to know if I, or they will be subject to the same policy.

Are you on a Bi-Level machine?

[btreger]

Yeah, in order for my insurance to cover a new machine, they require you to have owned your current machine for atleast 5 years and to get a new current Sleep Study to prove you still have sleep apnea. 

Thanks for responding. Sorry to read it. I guess all insurance companies aren't created equally. I know it was posted here some time ago that Medicare will let you upgrade after 5 years without having to get re-tested.

[btreger]

FDA's filings for Philips Respironics 
https://fda.report/Company/Respironics-Inc


Respironics Inc
FDA Filings
This page includes the latest FDA filings for Respironics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Interesting could use some interpretation to make more sense.
This is what I got from it, for whatever that is worth:
Respironics Inc
FDA Filings

FDA Registration(s)

I found (4) all with an Expiration Date of 2020-04-25

No idea what that means

Under Device Filings, there were only (2) listed after the recall

I could not find any information on the foam used for any of the listed products

[Zalagar]

Medi-Cal/Healthnet

No, I currently have a Dreamstation One, I started on CPAP, eventually went to APAP.

@RayBee, sorry I replied without a quote.

[MikeE3]

It would be interesting to see if indeed these new DS2's come pre-programmed.

So you're saying that your DS2 arrived pre-programmed to your pressure settings?

Mine didn't 'come' pre-programmed but shortly after powering it up, my settings were downloaded. I have been a Dreammapper user since starting CPAP with the DS1, if that matters. When I went to clinician mode, the settings matched my last current settings on the DS1 except for mask type. For that option it showed No or None, I forget right now. But I reset it to X1 which I found on the packaging of my Nasal Pillow Mask.

The X1, X2, etc. options confused me at first because the DS1 didn't use that terminology for setting the mask type.

[racprops]

Someone posted that the recalled Phillips machines are being sent to a medical disposal company.

Stericycle medical disposal company??

Indianapolis Medical Waste Disposal | Stericycle
[Search domain stericycle.com] https://www.stericycle.com/en-us/service...dianapolis
Stericycle is the trusted provider of medical waste disposal solutions throughout Indianapolis & surrounding areas, including Carmel and Bloomington. Learn more. Customer Service: 866-783-7422

Rich

[mrmagloo]

Interesting that they are not attempting to retrofit, at least initially.

[btreger]

Who will manage your repair or replacement?

Who will manage the timeline and status of your particular repair or replacement?

It depends upon where you acquired your machine.

A company spokesperson has suggested that if your machine was provided to you through a durable medical equipment (DME) provider, the DME will manage its replacement process and provide users with a timeline and status for their particular machine.

However, if a person registers their product independently of their DME, Philips and the DME will consult to determine which organization will manage the replacement process. If the DME authorizes Philips to replace your equipment, Philips will be in contact with you regarding the timeline and status.

What is the repair timeline?

It is unclear how long it will take for people to see their machines repaired. But, as PAP users may already be aware, visiting the various CPAP sales outlets shows that most devices not under recall remain in very low inventory or are completely sold out.

CPAPNation.com, as one example, has posted the following announcement on its website: "Due to a global supply chain shortage of CPAP devices, limited machines are available; however, we are committed to updating our stock on a daily basis & notifying our subscribers of any changes."

The replacement of the prior foam product with a newer, safer option that does not deteriorate will likely still be a swifter remedy than waiting for new machines to be built.


FDA Authorizes Philips to Fix Recalled PAP Machines (sleep-disorders.net)