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- เผยแพร่เมื่อ 4 ก.ค. 2024
- Caption at 1:18 should read Class 1 instead of Class 3
FDA Recall notice:
www.fda.gov/medical-devices/s...
FDA Recall Classification:
www.fda.gov/medical-devices/m...
Do you have a CPAP machine that has been affected by the recent recall from Philips Respironics? Not sure if you should continue use until you find another alternative for your therapy. In this video, we will be going over the reasons why you might want to discontinue the use or continue the use of your recalled machine. We do not recommend you continue to use your recalled device, but some patients might not have a choice because they cannot go without therapy. Before you decide to continue to use your recalled device we recommend speaking to your physician to make sure that you should continue use. After speaking with your physician and knowing if continued use would be right for you, we will give some tips to help. The main reason why your physician will tell you to continue the use of your recalled machine is that the benefit you are receiving from your device outway the risks explained in the recall. Patients with heart conditions that will suffer greatly due to the lack of therapy are candidates for continued use as well as patients that are highly susceptible to a stroke.
If it is determined by your physician that you should continue use there is something that you can do to prevent the debris from the foam degrading from entering your airway. You can use a bacteria filter between the machine and yourself creating a layer of protection. You do have to keep in mind that this will not help with the off-gassing of the foam but it will protect against any particles that will disperse. Bacteria filters can come in handy in this situation but you should not use a bacteria filter connected in line with a humidifier.
Chapters:
00:00 Intro
00:35 Investigation operations manual from the FDA website
01:46 Ventilator patients
03:13 Inline bacteria filter
05:30 Difficult times
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I pray to God that the damage has not been done. I had allergy type symptoms with the dream station and I’ve never had allergies. Fortunately I just purchased the Resmed airmini and started using it last night. This has been such a nightmare for so many🙏 Thank you for the update!
DITTO! Allergy symptoms same here. I exercise, lost weight, low carb, and lots of breathing exercises. Why don't they offer physical therapy breathing. Hello! We might get healthy.
Did all your symptoms go away when you started using the AirMini? Your welcome, and thank you for tuning in.
There is Respiratory Therapy depending on the condition that a patient might have. There is also plenty of breathing exercises.
@@Sleeplayground I just started using it 2 nights ago and I like it. Too early to tell if it improves those symptoms.
@@bassinRN Ok, let us know if you need any help.
My family doctor told me to be sure to use my bipap that it would help my heart (just diagnosed with a Fib). I told him it is recalled. He said to call my pulmonary dr. The nurse there advised me to continue use of bipap without the humidifier and the in line filter attached directly to the back of bipap. . So I went by and picked up a new in line filter in his office. I really hope Phiips replaces my machine soon!
I like the fact they told you to remove the humidifier, it shows they have good experience. Hopefully we all get replacement machines soon.
Lucy, I understand where you are coming from. 🙄
thanks for the update fortunately I still have my old reamed machine and the hose and mask from my dream station is compatible!!
That's awesome!
Just found out last week. Have only been getting the run around. Doctor said they only write the script and it's up to Philips to tell me if I should use my Cpac.
Philips says it's up to my doctor if I should use it
I can't afford to buy a new machine.
Unfortunately, the insurance is sending patients to Philips while they send you to your doctor which in turn sends you to the DME provider. The DME provider then sends you back to the insurance. It's a never-ending cycle.
@@Sleeplayground right
@@camelliaradhwan5928 its unfortunate, the only thing we can do is register our machines online and wait
Denise, the same thing happened to me. I called Philips and they said the same thing. Pushed it off on the doctor! They manufactured it! Tell the patient what they should do! Ugh! Asked my pulmonary doctor, primary doctor--- nobody knows. Frustrating, I understand. 🙄
It's a vicious circle. They keep passing it off to each other while not giving the patient any answers. Most likely because they do not want to be liable for anything. All of them just take your money and run.
Thank you! Wear can we get the new update on the new machine.
www.usa.philips.com/healthcare/e/sleep/communications/src-update If you register your machine they will inform you via email but the wait is long.
I have a Philips System One machine that I've used for 6.5 years. Opened it up (after 6 years' use) removed the foam, and continue to use it. By the way, the foam was NOT breaking down nor was it turning gooey, etc.. This happens from daily ozone cleaning (SoClean, etc.) that serves to break down the chemical composition of the common foam in these (and Dreamstation 1 /Go) machines. The foam there, too, is easily removed. If you like your Philips machines, look into removing the foam-- it's not hard to do.
Thank you for the advice!
Tell us more about this Air Sense 11, how is it different. Thanks
There's more on the way, make sure to subscribe to keep up to date with the latest videos.
My Phillips machine is not a dream station and started blowing foam out of it. I opened it and cleaned it and removed the foam. The machine still spits the foam. The blower is full of this sticky stuff. I run it w the humidifier to catch the foam, but after a few days, I still find foam particles in the water and occasionally in the napkin I adjusted at the end of the hose to catch anything flying out.
While that's certainly a way to handle it, here at Sleeplay we do not recommend MacGyvering a solution to a potentially hazardous machine defect!
@@Sleeplayground PATIENTS are being told the risk of the machine defect is lesser than the risk of death by apnea due to not using the machine. My experience has made very clear that most people commenting have not seen what the foam looks like when it has degrading and is leaking through the blower. IF you had, and you understood the legal liabilities involved, you MOST CERTAINLY would reconsider the recomendations. Philips is making recomendations the only way large corporations can make these decisions, by way of bean counters. If you had seen what I saw spewing out of the machine, plus these other details that were true in my case: 1) my insurance company will not replace machine overnight. 2) my insurance has required a new sleep study and I will get that on the 27th. This happened on the 13th. 3) the sleep lab will take 7-10 days to process my results, 4) the machine is spewing black sticky rubber pellets that stain the sheets like grease and dissolve between two fingers when rubbed. Blowing right out the tube. Fast. and Hard.
A) The integrity of the machine needed to be explored to be understood. And my doctor should have a lab in his office to handle such an inquiry for EVERY Phillips consumer on his patient roll. He should have called us to schedule a mandatory appointment. THEY check the foam ASAP.
In leui of responsible professionals, I took to TH-cam and found a video. I wasnt going to use the machine as it was. My first fix was to hook up the humidifier and see if it catches the particles. Caught a lot, but one made it out of the tube and that settled that. I wasnt going to be able to use the machine as it is. And it was not going to be refurbished, obviously.
So I followed the simple instructions, and opened it. I may have to make a video to share my photos.
I cleaned it completely and understood that i was not able to clean inside the blower. IT had the wires, didnt want to damage.
I wiped with a clorox wipe and removed chemicals with a clean damp cloth.
Cleaned the casing where the foam sat thoroghly. Blew it from afar with some air pressure.
Closed it back up. Tested it with humidifier again. Still caught lots of particles.
When I demonstrated the humidifier tub witht he black particles to the doctor he insisted I do not use the machine and proceeded to chart my future battery of tests in the appropriate intensity that matched my exasperated concerns. I was pissed.
Clean the accessories everyday. The soot will be black and you will see it on your breathing masks.
And if you were slightly technical, and patient, (you dont have to be technical, just patient and persistent) you could easily remove the foam before it degrades and not have to worry about this thing until you get sent a new machine by a new company. IT's that easy and when the foam is still in good shape, it hasnt made your machine defective in any way. Proceed with caution, but be confident. I wish I had done it in November, as I think my machine's foam started leaching since November for sure, and likely just a couple of weeks.....but get this, I saw my Doctor Dec. 9 as a response and he didnt think that because my machine was so old that it should be examined. That is not good medical advice. The devices need to be examined ASAP. By certified technicians, ideally and as a matter of course.
The issue is the PE-PUR foam that is used for sound abatement can degrade resulting in a host of issues including death Souce: FDA. I recommend requesting them to provide a shipping label to send your machine to a qualified testing facility for analysis. At their expense.
Unless or until this testing is conducted, you and they don’t know for sure if you may have been breathing in dangerous VOC’s. Don’t loose chain of custody with your machine by returning it.
Request Philips ship you a DreamStation II which uses silicone for sound abatement.
But my question is why is sound abatement material (foam) even allowed in the air influx compartment at all, where fresh air must flow through before entering out bodies where the air will become tainted & unnecessarily poses severe health risks, cancer & even death to its users? Soundproofing material has no place inside this area of our units. It should be encased in its own chamber & where it will not interfere with the medical breathing "RX" device that our doctors "PRESCRIBED" for us. Our CPAP, BIPAP & Ventilators, although not in pill-shape forms, ARE PRESCRIPTIONS none the less... prescriptions that our doctors PRESCRIBED for us to IMPROVE our health & well-being to better our lives.
Manufacturers of these kind of devices should have a separate, specialized "safe filter system" that is specifically designed to filter the air before it is inhaled by the patient. It sounds like the companies decided to play God with our lives by cutting corners in their product designs to save money & "kill two birds with one foam" that was known to be made of dangerous materials. Shame on you!
It is horffic & inexcusable that these products that were created to improve life had become grim reapers in disguise & that these companies are profiting from this kind of "treatment". Doctors & sleep specialists need to open their eyes & learn more about these RX products before they consider PRESCRIBING them. If they don't monitor & research these things for us, then who will? (I will not mention anything about greed, kickbacks, dirty money & personal/company gains from letting this continue for so many years when the dangers of using this foam was already known for years. The manufacturers of these devices should be shut down & their owners be fined & imprisoned.
The worst thing about all of thiHealthcare the trust in those who I entrusted with my healthcare.
I have lost faith & trust in these sleep products, in the sleep study industry as well as in some of my healthcare providers who made the decision to put my care in the hands of these corrupt companies. This is an unfathomable, despicable incident & cover up & yet we're still left footing the bill for "their caring ways" & products that are only pushing us closer & faster to an early grave. Unbelievable!
Philips has not yet stated if they will be replacing the machines or repairing them.
Hopefully they will correct this issue as soon as possible.
@@Sleeplayground philips CEO in a securities analyst meeting last week said that their current estimate is 2/3 repair and 1/3 replacement.
@@Sleeplayground according to the CEO in a conference call last week with securities analysts, he said timing was indeterminant and placed any holdup on the FDA. Furthermore, the company said it could take up to a year. The fact is they could begin replacing equipment now with DreamStation II’s which contain silicone foam, not the PE-PUR foam.
I use the Dreamstation CPAP all the time. Even when traveling, as I don't want to be without it. I never got a straight answer from the doctor or specialist concerning whether to continue using it. Very frustrating! Why should we have to pay for Philips Respirontics mistakes!? I got my machine through my insurance, and own it. After being diagnosed and using the CPAP since 1998 and then CPAP surgery in 2000, I still am in need of it. Please, Philips Respirontics, take the responsibility of replacing these machines, without charge, for us users. As for me, I am retired and do not have the funds for a new machine.
We understand that it is very frustrating. We hope that they continue to help patients like yourself as the year continues.
I know for a fact that I breathed in foam particles. Is there anything in the recall notice about what those of us who have been exposed should do? Also, I was wondering if humidity exchange filters which mount close to the mask are safe and effective at catching particles? I removed my foam, I just want to share as much information as possible with others.
They did not mention what the next step should be but we suggest you see a physician and explain what is going on. As far as hme filters go they might filter out the particles but there is also the part of the off-gassing and the hme wont do anything to protect you from that.
How do you know with such certainty that you inhaled the foam particles?
@@kenl16 One night I felt something go into my lungs...I thought it was dust or lint...I took my mask off and I assume I coughed it out...I changed my filter even though that didn't make sense...I'm not sure if it was the next morning or some time later but, I noticed that there were these black particles where the mask connects to the tubing. I assumed that they were lint or dust. Also, I had what I thought was dryness in my lungs even though I was trying to keep up on fluids. Once I heard about the recall and removed the foam my lungs felt much better in three days.
That's very interesting. Thanks for the info. How old was your machine when this happened?
What is really bad is the fact us patients who are in the recall who use the Trilogy ventilator, we have to stay on these ventilators, because they are LIFE SUPPORT! And we're waiting for our DMEs to have the solution so that we can get put on ventilators that aren't at risk for causing cancer! I'm using the viral filter like us ventilator patients are suppose to, but that's just keeping the foam from ending up in our lungs. The gas is still poisoning our lungs! THIS IS SICKENING!
Yes, you are correct and this is a very bad situation. You can ask you DME provider to see if they have the Trilogy EVO which is excluded from the recall.
I bought the plastic piece without the foam, used it last night and went perfect,
I went 10 months or so without it
We are glad it went well for you.
How about don’t put any foam in it at all?!?! I ripped my oily broken down tar foam out and my crapstation is just as quiet! My humidifier quit working after a year anyway.
That would have been the best option but as they say, hindsight is 20/20
@1:18 you mentioned class 1 but your video was captioned class 3… good info nonetheless…
Thank you for spotting, we did not notice.
@@Sleeplayground you're welcome :) it's one of my hobbies :)
Had my machine for 3 nights feel a bit better though headaches are constant
Hey, have those headaches gotten any better?
One once supposed sent to me a month ago trying to find out where it is
I am not understanding your statement. Can you please reiterate? I appreciate you very you much!
Is the dreamstation Phllips corrected and mailed to me safe to use? Was it fixed? Kp
Yes, it should be. A lot of people are still waiting for machine after years. We have a brand new Airsense 10 card to cloud for $449 right now. A lot of patient are just replacing.
Hi, is it only the dream station that’s affected. I phoned Phillips and gave them my reg. Number and they told me it wasn’t affected. It’s not a dream station.
The Dreamstation is the main machine but not the only one. check this bottom of this page (www.usa.philips.com/healthcare/e/sleep/communications/src-update) and you can see which machines have been affected.
I started using the dreamstation machine in December. I had two sinus infections. I stopped using the machine last week when I started feeling symptoms for another sinus infection. I feel fine now. I want to remove the foam. How do you do that ? I am waiting to go to the sleep clinic next month.
We recommend you take your machine to a certified repair station in your city. To take the foam out you have to take the machine apart.
Lots of videos online as to how to do it. I just did mine today.
They are changing out my dreams ration 1.i need to use it but it scars me because cancer runs in my family .and ì can't breath
I know this is a bad situation, speak to your physician to see what options you might have available to you.
It's been since 2020 since I've registered, abd still waiting, getting at most 4 hrs sleep a night
We are sorry to hear. Give them a call to see if they have any update.
Well that was clear as mud.
LOL!
Phillips don’t care have to use my machine contacted Phillips 8 weeks ago still waiting
I registered my machine right at the begining, All i've gotten is an email that it can take up to 12 months.
I am waiting on a dreams station 2
We've been able to work with a few and it seems that its a good machine
I'm scared to use mine anymore I'm immunosuppressed from my liver transplant I still have liver disease I have stage 3 chronic kidney disease I have Lambert Eaton syndrome I have nodules in my lungs now I don't need any other issues
Understood completely!
Okay I use a bipap so how much does this cost out of pocket
Depends what therapy you need, and the machine is available.
@1:20 you read class 1, but the title is class 3. Either way I am probably F’d because I am still using my machine and Phillips is not doing anything to remedy this situation in a timely manner.
Thanks for pointing that out. We hope your situation works out. Let us know if there's anything we can do!
What is the cost of a new cpap machine?
Hi, you can check out all available CPAP machines and prices here: sleeplay.com/collections/cpap-machines
No one has the money these days to buy another one out of pocket. You say on one hand there is a shortage but on other hand that you have them. CPAP machine companies can’t negotiate a bigger price due to regulations but have found a way around that huh. How much are your comoanies? Double or triple what they usually are?
Yes there is a shortage. We have been able to receive very few machines from the manufacturers, most machines have been purchased from other retailers at full price to keep stock for our customers.
I can't afford to buy a new machine and they don't have a loaner where I bought the machine. If I don't use the CPAP I get a migraine. If they require my machine be sent into fix that will not work. So I feel I am screwed. I will not buy any Philips products because of this.
You should speak to your doctor and see if you can get a new machine through the insurance as the one you have is hazardous.
@@Sleeplayground I couldn't get in before August 24. I hope I will be able to get a new one. Thanks for your reply.
@@montanablue7960 Hopefully Philips Respironics makes this right.
I called Philips Respironics customer service last week to get an update on the recall and the rep stated that Philips is waiting on the FDA and as soon as the FDA approves,every patient that registered their Cpap/Apap on the recall website will receive a brand new replacement.
@@vegaluis956 Hopefully sooner than later.
My advice. Get the foam out, find a friend who's good with their hands /problem solving,I removed all mine in my M series, it wasn't supposed to be involved in recall but was amazed at what I found inside , bad s##t. Get it out any way you can
Yes, a lot of patients are doing this because we don't have any insight as to how long this is going to take.
If we take out the foam does it void the recall in anyway.
@@Cowboy-Trucking61 possibly but to stop the total toxicity to your cells it's either get the crap out or stop using it. Make no mistake it's bad s##t that's awful for many parts of your body. Good luck friend 👍
@@Cowboy-Trucking61 just don't tell them you removed anything, I told my doctor+showed him pics of what I found inside. My machine still works the same. My doctor is fine with it.
Where is the crud?
Bro, you have the thickest Miami accent ever. I gotta save this vid to show people what a Miami accent is. 😃
Go for it!
Anyone experiencing a red chest rash?
No one has complained about a chest rash, you have a dreamstation?
Wen the truck come out my 2000 dollars machine is int the bag can’t be used can I get my money back
We hope with the latest update that everyone's machine will be exchanged in a timely manner but as far as money back you would have to contact Respironics directly.
You need to pull this misleading video down. As An RN stated, you have your recall definitions backwards. you state that the Dreamstaion recall is a Level One, but have the definition for Level 3 listed (and labelled as Level 1). The same is true for your Level 3 definition (it's actually the Level 1 definition). I just noticed that you have posted a note in the description. This only covers half of your bad information. This sort of medical mis-information could result in a YT strike or worse - liability issues. Redo this video or delete it would be my advice. It reflects very poorly on your business.
Not trying to spread misinformation, the information on the video is directly from the FDA's website. The Level 1 part was an editing mistake that labeled it incorrectly and that's why we mentioned it in the description of the video.
Does medicare pay for a Cpap?
Yes, they do. They allow 1 every 5 years
Yes they do. If you have been diagnosed and had a sleep study test done, they will put it through Medicare or whatever insurance you have. Word of advise---be sure to use it every night. They monitor usage. If after a year, you have consistently used it every night, you own it. If you don't use it, they will send someone to pick it up!
Maybe get a lav mic.
Thank you for the feed back
How on earth could a respiratory product specialty expert company not have realized the risk of off gas from foam???!!!! Negligence & profit. How can anyone trust any of these makers now?
It seems that they were aware of this issue for a while but the percentage of affected individuals remained very low until recently.
The risk isn't from off-gassing. If the foam is physically breaking down, minute particles become loose and are blown into the breathing tube, potentially being drawn into your mouth and into your lungs. That is NOT off-gassing.
Worthless info.
thank you for the feedback
Do Preacher all lie like this guy?
Sorry, you feel this way, We are providing the best updates possible for our community. If something stated in the video is incorrect please inform us so we can correct it. Thank you