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

[DaveL]

This is a research and also a clinical area of mine for about 20 years and I have heard over and over from people who felt like they were blamed for their apnea. If only they would lose weight, for example. Family members and friends may not understand. There is a great deal of stigma associated with this for many people. Take control refers to empowerment. How many people are given an active role in their care where they are taught to understand data and settings, given a choice of machine, supported and worked with to have an active role in their treatment? How many people turn to discussion boards and internet groups because they are not getting the help and support they know they need (and should have)? In many chronic conditions, people have extensive support groups, education, followup, etc. to ensure they are educated and involved. There are numerous concepts in medical research about patient engagement and activation. Some facilities are much better about that now than they used to be. But not all.  Too often I know from my own clinical experience and my research the emphasis is on compliance and people can feel threatened that "they'll take your machine away if you don't use it enough." People have told me they felt in "limbo" because of such a lack of information. Take control means be an active participant in your own care (to the extent that you want) and not be forced into passivity which is pervasive in this field. Take control would include having access to your own data and understanding it. I don't want smiley faces on my machine. I want all the numbers, and as a patient with a chronic and serious medical condition, I should have that without having to rely on discussion boards to help me understand my own care. That is taking control, as people here have done by filling in those gaps. I think those gaps should be smaller and fewer.

Welcome to the forum sleeprn.  Well written.  

My sleep-doc-from-h*ll said, "be compliant or I'll take your Driver's License away."  And about changing pressure, "practicing medicine without a license."  Toronto, Ontario Canada Dr Inouye.

[racprops]

I hear it the other way, it is a western saying....

[cathyf]

Here's from the FDA letter about the recall: https://www.fda.gov/medical-devices/safe...alth-risks

BiPap or CPAP: Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers

• Talk to your health care provider to decide on a suitable treatment for your condition, which may include:
  • Stopping use of your device
    
  • Using another similar device that is not part of the recall
    
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
    
  • Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.
    
  • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
    

There you go -- just lose some weight and stop drinking and smoking and your apnea will go away!

That was 16 days after the recall. Now the notice the day after the recall shows what they think is really important: https://www.fda.gov/safety/recalls-marke...ement-foam

In terms of the financial impact, Philips anticipates that the expected revenue headwinds in the Sleep & Respiratory Care business in 2021 will be compensated by the strength of the company’s other businesses. Therefore, the full year comparable sales growth and Adjusted EBITA margin guidance provided on April 26, 2021 remains unchanged.

The updated instructions for use of the affected devices have resulted in adjustments to and acceleration of the repair and replacement program, as well as intensified communication with customers and patients. This had led to an increase of EUR 250 million in the expected costs of the corrective actions on the installed base, in addition to the provision that the company recorded in the first quarter of 2021.

Translation: the ghouls in the ventilator racket made out like bandits overcharging for ventilators during the pandemic...

[archangle]

Has anyone heard the status of us criminals who are using CPAP machines not obtained through a DME, with a prescription, etc? 

i.e.  I'm not the person who bought the machine from a DME, Maybe I don't even have a prescription.  If I contact Philips, are they going to repair or replace my CPAP machine?  Are they going to tell me to go to my DME and/or require me to have a prescription?

[cathyf]

This is a research and also a clinical area of mine for about 20 years and I have heard over and over from people who felt like they were blamed for their apnea. If only they would lose weight, for example. Family members and friends may not understand. There is a great deal of stigma associated with this for many people. Take control refers to empowerment. How many people are given an active role in their care where they are taught to understand data and settings, given a choice of machine, supported and worked with to have an active role in their treatment?
...
Too often I know from my own clinical experience and my research the emphasis is on compliance and people can feel threatened that "they'll take your machine away if you don't use it enough." People have told me they felt in "limbo" because of such a lack of information. Take control means be an active participant in your own care (to the extent that you want) and not be forced into passivity which is pervasive in this field. Take control would include having access to your own data and understanding it. I don't want smiley faces on my machine. I want all the numbers, and as a patient with a chronic and serious medical condition, I should have that without having to rely on discussion boards to help me understand my own care. That is taking control, as people here have done by filling in those gaps. I think those gaps should be smaller and fewer.

The first thing that I learned as a sleep apnea patient is that the seriousness of my disease varies wildly according to the convenience of the medical professionals involved. They alternate between haranguing me in advance for my anticipated disobedience to ignoring me entirely.

I've been saying for nearly seven years that everything you need to know about sleep medicine is summed up in the fact that they use the word "compliance" to refer to the "decisions" that people make when they are freaking unconscious! They don't even try to hide their contempt for us!

Everyone here talks about doctors and dme's etc trying to prevent you from seeing your data as about control and them not wanting to give up control to the patient. I think it's exactly the opposite. They don't want the patients looking at the data because once the patients see their data they realize immediately that no one else is looking at their data and no one else will look at their data (and none of them give a rip about the data, or the patient)! The first thing you realize when you take control is that none of these people has ever had the slightest interest in being in control. They only want to play dog-in-the-manger to keep you from being in control!

On March 18th I drove over an hour for my appointment with the head of the Neurological Institute big hospital system sleep center. I brought in my card, and this was the night before:
[attachment=33743]
Screen Shot 2021-07-13 at 10.29.52 PM.png

Here's a closeup of one of those clusters:
[attachment=33744]
Screen Shot 2021-07-13 at 10.29.27 PM.png

Notice that hot mess in the closeup has a local AHI of 71. Here's what the gaslighting app (MyAir) had to say about it:

Day
3/17/2021
Usage hours
5.3
mask on/off
5
Maximum mask leak
32.4
Maximum mask leak in seconds
0.54
Leak 95th percentile
13.2
Leak 95th percentile in seconds
0.22
Median mask leak
0
Median mask leak in seconds
0
Leak 70th percentile
2.4
Leak 70th percentile in seconds
0.04
Apnea Hypopnea Index (AHI)
13.9
Apnea Index
13
Hypopnea Index
0.9
Central Apnea Index
0.1
Obstructed Airway Apnea Index
12.4
Unknown Apnea Index
0.3
myAir score leak 
20
myAir score usage 
53
myAir score AHI 
2
myAir score mask on/off 
1
myAir score
76

The machine gave itself a freaking 2 out of 5 AHI points for an AHI of freaking 13.9! There were clusters where the local AHI was 60-70-80, the machine was totally helpless to do anything about it, and that was worth a ding of just 3 points?!? On the other hand, me cycling the the power five times was a ding of four points! Because, you know, the machine is not for treating apnea -- apparently I must have heard wrong. This machine is not for the treatment of sleep apnea, but rather the exotic disease of masque taykinuff.

If anyone there had actually looked at the data they would have seriously questioned if I should have been driving on the way there, and if I should drive home when I left! But, no, it was all happy faces!

Disintegrating foam and sham recalls and sneering at you for being a fat drunken smoker -- those just symptoms -- and there are many other symptoms -- of their contempt for us.

[Redrum]

So the information seems to indicate that offgasing of VOCs, at hazardous levels, only occurs during the first 24 hours of use.  If this is true I may just risk using the machine a little while longer until it is fixed by Phillips.

On the other hand, is that information trustworthy coming from Phillips themselves?

Can’t trust that information. You will wait a long time for Philips, might take over a year. Try to get a replacement somehow

[racprops]

When I was told by the Hospital after my quad bypass three things: My cholesterol was still borderline, that I had sleep apnea and the operation when very well.

So what caused my blocked arteries??

I then got tested and was told I have very bad sleep Apnea.

I joined this site and another one like it.

Here is my findings:

Why CPAP??

I feel people thinking of not using their machines need to see WHY they should keep them and learn to live with them as there is a real chance they will not live long without them.


I had a quad bypass in Jan 2013. I was told a number of things, that my Cholesterol was borderline even at that time, and that I had sleep apnea. Reading how sleep apnea CAN cause cardiovascular disease I got tested and was told I suffer from major sleep apnea and that I have complex sleep apneas. And that I needed an ASV machine.

I understand how many find using one of these systems painful.

Well, I spent three months recovering from the surgery, fairly painful. It was over two months before I could sleep in my bed, I spent those months in my Lazyboy Recliner…I could not lay down, I read up on why, seems it happens to a lot of people recovering from such major surgery, it is problem in our memory of what happened the last time we laid down on a bed/table.

It was nearly 6 months before I was fully able to do everything I used to do before the surgery.

I wanted to live, and at 64 I felt that is TOO young to die, so I lost 40 pounds, ate/eat much better, and did whatever I could to improve my health.

Trust me, the pain of a quad bypass is much, much worst than any small discomfort wearing a sleep mask.

And even if you need to pay for it out of your own pocket much cheaper than $140 to 250K in medical bills.

And again Why CPAP: From one RN:” As a former ICU who cared for brain dead patients who’d suffered massive heart attacks in their sleep from untreated sleep apnea, I can assure you that’s not the case. It’s hard to appreciate the heart attack or stroke you didn’t have!”

I researched this subject worldwide so that I could see findings that might NOT be biased by the American Money making Doctors, as I seemed to find that this was lazy or poor Doctors haven, where all he need to do is damn near nothing, but hire some sleep techs who do the all-night sleep studies, write the reports and all they need do is rubber-stamp the report and write the prescription. And it is very hard to sue a sleep doctor for malpractice and it is nearly impossible to harm anyone with a sleep machine.

Deaths are almost always by other medical problems.

I found this kind of medical science reports worldwide:

The American Sleep Apnea Association estimates that 38,000 people in the United States die each year from heart disease with sleep apnea as a complicating factor.

People with sleep apnea have difficulty breathing or stop breathing for short periods while sleeping. This treatable sleep disorder often goes undiagnosed.

According to the American Heart Association, 1 in 5 adults has sleep apnea to some degree. It is more common in men than in women. Children can also have sleep apnea.

Without treatment, sleep apnea can lead to serious complications.

It may lead to or worsen several life-threatening conditions, including:
• high blood pressure
• stroke
• sudden cardiac (heart) death
• asthma
• COPD
• diabetes mellitus
Dangers of sleep apnea without treatment: What the research says

Sleep apnea causes hypoxia (a low oxygen level in the body). When this happens, your body becomes stressed and reacts with a fight-or-flight response, which causes your heart to beat faster and your arteries to narrow.

Heart and vascular effects include:
• higher blood pressure
• higher heart rate
• higher blood volume
• more inflammation and stress
•
These effects increase the risk of cardiovascular problems.

A 2010 study published in the American Journal of Respiratory and Critical Care Medicine found that having sleep apnea can raise your risk of a stroke by two or three times.

A 2007 study from Yale School of Medicine warns that sleep apnea can increase the chance of heart attack or death by 30 percent over a period of four to five years.

According to a 2013 study in the Journal of the American College of Cardiology, people with sleep apnea have a higher risk of death from related cardiac complications. The study found that sleep apnea can increase the risk of sudden cardiac death.

This is most likely if you:
• are older than 60 years of age
• have 20 or more apnea episodes per hour of sleep
• have a blood oxygen level of less than 78 percent during sleep
•
According to a 2011 medical review, up to 60 percent of people with heart failure also have sleep apnea. Adults in the study who were also treated for sleep apnea had a better two-year survival rate than those who were not. Sleep apnea can cause or worsen heart conditions.

The National Sleep Foundation notes that people with sleep apnea and atrial fibrillation (irregular heart rhythm) have only a 40 percent chance of needing further heart treatment if both conditions are treated.

If sleep apnea remains untreated, the chance of needing further treatment for atrial fibrillation goes up to 80 percent.

Another study at Yale linked sleep apnea and type 2 diabetes. It found that adults with sleep apnea had more than double the risk of getting diabetes as compared to people without sleep apnea.

Sleep apnea types
There are three main types of sleep apnea:
• Central sleep apnea. This type happens when your brain doesn’t send the right signals to the muscles that control your breathing.
• Obstructive sleep apnea. This is the most common type and happens when your airway narrows or becomes blocked.
• Complex sleep apnea syndrome. This is a combination of central sleep apnea and obstructive sleep apnea.

Here is the good news about my life on CPAP:

A. I believe my use of CPAP had nearly cured my lifelong hay fever. I believe this happened by the filters and that the pressure stops my runny nose and that with 7 to 8 hours nightly of this treatment has trained my sinuses to stop flowing. I found from the beginning the system would stop and then clear my nose within about an hour after putting on my mask and running with the humidifier turned off.


B. My heart seems very healthy, and in the 8 years since my quad bypass my blood pressure has improved and I have not had to change my blood pressure medicine of lowest dose of 2.5 MM of Amlodipine.


C. With a good ASV machine I am enjoying some of the best health I have had in the past decade. At 73 years this is great.


D. I really enjoy a childhood thing, during the winter I can throw the covers over my head and unlike the old days can sleep all night under the covers as I do not run out of air.


E. Lastly it is a comfort to know NO bugs or anything can touch my face while sleeping.

[racprops]

I did think it almost looked like a scam, an almost fake medical problem, and sadly what cathyf said has been true in my Esperance as well.

I have not found what I would consider a real good sleep doctor.

So it does seem like they don't really care.

But if you see a lot of doctors they all kind of seem like that...And I saw a lot of doctors:

More on sleep and my machines and problems:

I was on Medicare and access so I asked my PCP to replace my bad ASV machine…( I now believe what I was having trouble with is a minor problem with all ASV machines...)but they demanded a new sleep study, and then would only provide an APAP machine.

I was showing low AHI numbers so figured THEY were right but I was still crashing nearly every day with only about a couple of hours of being alert….this was very depressing so I looked for help:

I then spent the next two/three years seeing every Doctor I could.

The findings were all the same. They could not find any cause of my crashes. I joking said the Dr.s all said, “ I will live to 125 IF I don’t mind doing it so very tired getting there.”

I was at my wit's end…

Then two things turned up. The first was my wife received a Fitbit HR for Christmas.

This device seems to be able to monitor sleep cycles. Not just how long one sleeps but the sleep cycles like Light, REM, and Deep.

An important report of the Fitbit, it CANNOT report any sleep cycle of fewer than three hours. As I was wakened more often than that I was a little hard to get full night’s sleep reports.

I found there are a number of systems to monitor your sleep cycles, I use a system by Resmed called Sleep Score Max, a good system that can give a fairly accurate of all your sleep cycles.

REM and Deep sleep cycles are very important. With low or no REM and Deep sleep cycles, you cannot function. I found that there are a lot of science reports on this subject.

I got a Fitbit HR (For Heart Rate) first and found my replacement simple CPAP Machine was badly overreacting and stopping most of my REM and Deep sleep cycles. I matched their time stamps and saw every time I entered REM or Deep sleep the APAP would overreact after each event and raise pressure to the point I was aroused and pushed out of either cycle, IT was shortchanging these sleep cycles.

I read up on how these machines treat apneas.

On the simple machines (not a ASV) they can do NOTHING during an apnea event, all the system can do is wait until it is over and then raise the pressure to hopefully PREVENT the next event..and if it happens again the system will do NOTHING during an apnea event all the system can do it wait until it is over and then raise the pressure to hopefully PREVENT the next event, and again and again, to the point that it prevents any apneas.

The problem I fought with these systems is often the pressure changes upward would often either cause arousals OR raise the pressure so high it cause mask farts and woke me fully up.

Here is one major reason I love my ASV machines: They can take action DURING AN APNEA EVENT!! They can and will try to make you breath, they will push air as a breath or even breath for you (as much as they can…) into your lungs.

And if they do succeed then the system will relax and NOT take any major action like jacking up the main pressure, it can return to your base setting waiting for the next event.

So I dug out my older ASV machine (a much better sleep machine, Adaptive Servo-Ventilation Machines) and did a complete setup. I soon found I have was having a major improvement in my days; my sleep cycles are much better giving me much better days.

I have had to find ways to buy or rebuild these costly machines, but in my case, they are the only way for me to have a much better life.

I have learned as much about these machines as I can, and found that I am understanding them better than my sleep doctors, and almost all repair/service techs.

There is no troubleshooting.

There are only three courses of action, replace a noisy fan, replace the mainboard, or replace the whole machine.

Simple.

I learned how the treatment is supposed to go and perform it myself on myself.

I learned NOT to obsess over getting total low numbers as that seems to cause GERD Acid Reflux (Heartburn) ...problems with me.

I can get 0.0s if I push the pressures but as above found allowing a few Apneas lowers my GERD, and yes I saw an Dr. about this problem and had Interscope performed to confirm it.

So by learning as much as I can and treating both my sleep apneas AND my sleep cycles and buying my own ASV Machines I am enjoying some of the best health I can.

I also try to share what I seem to know with others as much as I can.

I personally think everyone would be much better off and much happier with both a good ASV machine AND a sleep cycle monitor.

At least I am.

Rich

[DaveL]

@cathyf 



There's no common sense in this "disease" and it's treatment. 
I've been a hoser for over 30 years. Compliant.

On bad days I think it's a manufactured disease. 

Most days I feel grateful. I've discovered this forum. I've learned to listen to recommendations. I feel better. Most days.



Thank heaven I didn't buy a Respironics machine. Sleep Doc would have written an Rx for one; I objected.

[sleeprn]

Well, again this depends on rather you believe THEM.

My materials guy states "All foam breaks down soon or later", perhaps it will be safe for the Stated 5 years lifetime, but I plan on using my machines for 25 years.

Rich

SO I want no foam in any of my machines.

Third party independent tests are needed for sure. We would look for that with other devices, for example, the UL listing on a coffee pot. Something beyond the manufacturer's "trust me," which we know we can't in many cases.

I wonder if any foam is a problem, for example foam attached to the casing/housing, or is it just foam in the airflow path? What are your thoughts on that? Perhaps there is an option for safe, independently tested, no foam machines that can be placed in an isolation box to muffle sound as long as there was adequate ventilation and air? Just curious. Seems there is a lot of room for innovation in this area. At least we've come a long way from the vacuum cleaner type motors of the original devices.