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Old 09-04-2021, 01:15 AM   #1
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resperonics sleep machines

I know this has nothing to do with boating but i wanted to get this info out.
For all those with sleep apnia equipment resperonics has anounced a recall and immediate discontinuing of most of there machines do to cancer causing problems. My wife didnt discover this until she went to make a waranty claim on one of her machines. This is a world wide recall with no solution. I can not believe this has not been made public. If you use a resperonics machine you need to register on there site and consult your doctor. My wifes doctor said to discontinue use and buy a new machine,out of pocket, since her machine is less then 5 years old. This is only resperonics. I am really disappointed that no notice or news coverage on a medical device that effects thousand of people is out there. she still has gotten no notice from the manufacture and the cpap company she bought the machine from is no longer answering there phone.
Thoughts?
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Old 09-04-2021, 01:24 AM   #2
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Just found this.

https://healthycanadians.gc.ca/recal...76137a-eng.php
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Old 09-04-2021, 01:44 AM   #3
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Fortunately we had a new res-med machine so she was able to have a solution. In my head this is such a big deal. If anyone gets lung cancer that used a machine there is going to be hell to pay. What really surprises me is i see recall an car seats and cribs and such that seem to be more parenting then manufacturing all the time on the news but nothing on this. I hope this blows up on Philips. They were supposed to send a filter to put in line to catch the larger partials but nothing after a month.
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Old 09-04-2021, 05:27 AM   #4
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Link

https://www.tga.gov.au/alert/philips...al-ventilators
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Old 09-04-2021, 05:47 AM   #5
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I assume you’ve gone here:

https://www.usa.philips.com/healthca...E&gclsrc=aw.ds

If you’re not getting any action from Philips, I think you should contact the FDA, they ordered the recall in the US.

I remember seeing this on the news a while back, there were some stories about this.
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Old 09-04-2021, 06:00 AM   #6
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I have a degree in sleep medicine so have interest in this subject although now retired. The recall is being handled poorly in the USA in my humble opinion.
Medicare still requires a 5 year interval between replacement of C and Auto PAP machines. Phillips has a registration mechanism on the internet but makes no promises about when a replacement will be available. Cost of a new machine is ~$1000.
Mitigating this some what is risks maybe not be that high from available information but it seems clear risk is presence. Resmed apparently is not having similar issues.
Would suggest if you have a Phillips machine go to their web site now and register it. Call your provider. Find out if you can get a Resmed, or other brand covered by insurance. If not then you have a difficult decision. I called the durable medical device vendor we’d mostly dealt with. They say at present they are unaware of any reimbursement protocol should you buy an alternative out of pocket while this sorts out.
Do think it’s important you continue therapy so it’s worth the effort to figure out a plan.
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Old 09-04-2021, 06:30 AM   #7
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Magna thank you for the post. Hippocampus thank you for sharing your knowlege.
A buddy who never could use a machine claims no if no snoring no breathing stoppage so he just tapes his lips shut! Cancer is too scary, I am tempted to temorarly try it.
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Old 09-04-2021, 07:07 AM   #8
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Resperonics isn't putting the word out? Maybe I've just discovered an avenue for augmenting my retirement funds, eh?
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Old 09-04-2021, 10:38 AM   #9
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Resperonics isn't putting the word out? Maybe I've just discovered an avenue for augmenting my retirement funds, eh?
You got that right. This is really a simple class action. A durable medical device approved by the fda producing known cancer carcinogens.

I just want to get the word out to those who need to know.
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Old 09-04-2021, 12:44 PM   #10
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I just went to the companies web site, and registered my wife's device.
We were not aware of the recall.

THANKS EVERYONE!
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Old 09-04-2021, 02:29 PM   #11
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I too have a recalled Phillips CPAP. I knew of the recall...from news reports, registered, received letter from Phillips; I also received a letter and phone call from my medical equip supplier. Supplier advises difficult to impossible to get new machine at this time- supply shortages for obvious reasons. Supplier and sleep doc both confirmed there is no way to know when/if Philips will be repairing, replacing existing machines. Sleep doc advised that risk "extremely low" and for many people the risk of not using CPAP far outweighs the risk of using the recalled machine. I guess it will be up to individuals working with their docs to make a decision. I do know there are resmed machines out there and some people I know of seem to have an "in" to get one. Medicare does only replace after 5 years but again, supply shortages will impact the ability to even do a scheduled replacement.

Oh, and as one would expect, there are already numerous law firms seeking "clients" for a potential law suit. Just need to Google it.
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Old 09-04-2021, 02:32 PM   #12
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Relative going through this.

The newest Philip’s machines, like the Dreamstation 2, apparently not affected. Go to their website to check.
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Old 09-04-2021, 04:17 PM   #13
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Thanks for mentioning this.

I have a friend with a CPAP (we happened to be traveling in tandem when he first got going with it so it was a topic of conversation then).

I gave him a call but he has a ResMed (whew). He bought a spare last year (same model; Craigslist) which now sounds like a good thing since they will probably be unobtanium for awhile.

Looked at the recall and it sounds like the culprit is some sound-attenuating foam in the machine. It either breaks down or deteriorates in some deleterious way. Ugh.

Maybe I'm too much of a DIY-er (probably a no-no on medical devices), but I'd be tempted to try to get that foam out of there. Especially if there is a shortage on replacement machines. (Not that I've looked into the details.)

Buddy mentioned above has the machine in a bedside cabinet with just the hose coming out, so a bit louder would not (have been) a problem.
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Old 09-04-2021, 10:03 PM   #14
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my wife had to do a new sleep study to get a new machine. She is there tonight. I am surprised they are working on a weekend over the holiday. With the new study she can get a new resmed if available. Fortunately she is able to use my spare ,which was on the boat, while she waits.
I am just hopeful to get the word out.
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Old 09-08-2021, 10:58 AM   #15
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Expect back ordering on all non Phillips
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Old 09-08-2021, 01:48 PM   #16
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I know this has to be nerve-wracking for the OP and his family. We had a scary, frustrating experience with sleep disorder treatment that I hope is on topic here.

After my wife had a sleep study, we received an urgent call from her doc telling us to cut short our vacation and see her immediately. The study showed that my wife had central apnea—a more serious, neurologically based form of apnea which can stress the heart. She was put on a CPAP machine but could never adjust to it. A second study by a different hospital confirmed the first—central apnea—and she was put on a biPAP machine. Same problems with adjusting and going without sleep.

I decided enough was enough and took her to the sleep center at the Mayo Clinic. After having the “gold standard” sleep study, she was told she had garden-variety, moderate, obstructive sleep apnea. She bought a $400 dental device to extend her jaw and now sleeps like a baby. After many thousands of dollars and countless nights of lost sleep—both hers and mine as I worried about her—she’s fine. Mayo was great, but i found myself wondering if sleep studies are inherently inaccurate or whether this branch of medicine is still in its infancy?
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Old 09-08-2021, 07:51 PM   #17
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As one board certified in sleep medicine can reassure you the field is not in its infancy. Unfortunately just like plumbers there’s good ones and not so much. Confounding the field further there’s ENT, pulmonary medicine and neurologists who have gotten boarded in this field so come from different backgrounds
I trained in a Harvard affiliated program, kept up on the literature so felt confident in my skill set.
General advice. Although home testing is adequate for the most common form that being simple obstructive sleep apnea testing in lab in a ASA lab with a certified tech and read by a sleep boarded physician remains the gold standard. Unfortunately due to insurance issues it may take extra effort on the part of physician to get it done.
As with any physician bedside manner doesn’t speak to fundamental skill set. Pay attention to where they trained, what other boards they hold, is the lab certified, and who is the reader. Also as a broad generalization looking at the organization of the lab may be of interest. Is it part of a hospital or private, is the hospital a primary or tertiary center.
Currently there are multiple different devices used for home testing. This adds some degree of variability. Patients may have different levels of compliance to the testing protocol or sufficient fragmented sleep or other issues making the study non diagnosic or incorrect. Generally doing two nights of home testing is more reliable. Fortunately usually (in my area at least) can usually get 2 nights covered by insurance.
As regards interventions some form PAP usually is best. Current machines allow recording the AHI (how many apneas per unit time) during therapy. The fine points of using a fixed pressure setting or an AutoPAP device is beyond the scope of this discussion. However, if any intervention other than a PAP device (which allows a reliable way to judge efficacy) is employed would suggest beyond clinical response a repeat study after institution of that intervention be done. I believe this is particularly important for anything beyond very mild sleep apnea.
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Old 09-08-2021, 08:29 PM   #18
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I've been using two of the affected machines for years. One of them is nearly ten years old now. This is the first I've heard of any of this. Thanks for posting.
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Old 09-08-2021, 10:02 PM   #19
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Originally Posted by Hippocampus View Post
As one board certified in sleep medicine can reassure you the field is not in its infancy. Unfortunately just like plumbers there’s good ones and not so much. Confounding the field further there’s ENT, pulmonary medicine and neurologists who have gotten boarded in this field so come from different backgrounds
I trained in a Harvard affiliated program, kept up on the literature so felt confident in my skill set.
General advice. Although home testing is adequate for the most common form that being simple obstructive sleep apnea testing in lab in a ASA lab with a certified tech and read by a sleep boarded physician remains the gold standard. Unfortunately due to insurance issues it may take extra effort on the part of physician to get it done.
As with any physician bedside manner doesn’t speak to fundamental skill set. Pay attention to where they trained, what other boards they hold, is the lab certified, and who is the reader. Also as a broad generalization looking at the organization of the lab may be of interest. Is it part of a hospital or private, is the hospital a primary or tertiary center.
Currently there are multiple different devices used for home testing. This adds some degree of variability. Patients may have different levels of compliance to the testing protocol or sufficient fragmented sleep or other issues making the study non diagnosic or incorrect. Generally doing two nights of home testing is more reliable. Fortunately usually (in my area at least) can usually get 2 nights covered by insurance.
As regards interventions some form PAP usually is best. Current machines allow recording the AHI (how many apneas per unit time) during therapy. The fine points of using a fixed pressure setting or an AutoPAP device is beyond the scope of this discussion. However, if any intervention other than a PAP device (which allows a reliable way to judge efficacy) is employed would suggest beyond clinical response a repeat study after institution of that intervention be done. I believe this is particularly important for anything beyond very mild sleep apnea.
Brilliant! Thanks very much for clarifying this.
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Old 09-08-2021, 11:23 PM   #20
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i was diagnosed with apnia several years ago and ended up with resmed and have went thru 4 or 5 generations of machines. Since i cant sleep without one ,likely psychological,i have allways kept new spars bought out of pocket. She started with resperonics and never got a choice of machines . she had her original machine and i got her a spare she could keep on the boat. The spare was not working correctly and under warranty so that is how i discovered the recall. I gave her the spare resmed and she registered in her name. Its the newest model and she loves it and will not be going back to her previous design. The dealer contacted me today regarding her machine and told me all resmed inventory was now back ordered and they doubled there price. He was good enough to tell me he would jump me in line and reduce the cost since i have bought all my machines from him but at this point just glad i had new machines as spares just never thought i would need on for this type of situation.
I just really want to get the word out so people can make there own choices regarding there health.I have no cause to bitch about how respironics has handled this i just wish the media would help get the word out so folks can decide what they wasnt to do. I have ran into at least a dozen cpap users who were un aware. This should not be.
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