Cushion popping in resmed quattro fx mask

[ziipppp]

Hah, I'm LOVING this thread. Ingenuity at work. I really wish the Quattro FX guys had spent half as much time as you folks thinking about this (and maybe testing it). So I was inspired by the floss idea and I hadn't checked in on this thread, so came up with my own solution. Frankly, I think I prefer yours, as its simpler - my only concern is not compromising the seal around the nose. Anyway, in the spirit of sharing here it is. I actually used a needle and thread and pierced that top tab - ran the thread down the front of the mask. Then wrapped a band around the el tube at the bottom - and cinched the thread there. This means the thread is steadily pulled and keeps that top tab under tension.

Hopefully this picture will help:



The changes in functionality are dramatic! I've been sleeping with this mask for over a year now, but the last few nights have literally been a dream.

I've already noticed the following changes:

1) I now realize I was really cinching down the upper straps to effectively "push" the hard plastic frame onto the cushion and thence onto my face to keep the cushion from unseating - this was where I had ended up over the course of the year but it happened so gradually I didn't realize it. Suddenly last week I woke up in the middle of the night and thought, "hey I bet I could back off on all this upper strap pressure" - did so and Presto! Better sealing mask, MUCH better comfort - and of course no leaks and no cushion coming undone. Just amazing.

2) I realize that there has always been a bit of background stress about the mask coming out; with the washing it in cold water, and then wiggling it in the seating, and falling asleep thinking "please god, let this thing not pop out tonight" - suddenly all of that has gone away. Again, because it had been happening gradually I didn't realize how much mental process and stress went into it. But now its gone away - just joy.

3) Now with the mask seal, I've moved the strap back towards more the top of my head and the "proper" position, which has also backed off pressure on the nose.

4) My large leak and AHI numbers have come down already - and I'm only 5 days into this. Excited to see where they will end up.

Anyway, just wanted to thank everyone for thinking about this, for the original floss suggestion, for the rubber band pictures, for the new improved rigged head gear and for all the great thought you guys have put into this. Life changing!

Seems that Respironics version of the mask might also be worth checking out - but in the mean time thanks a million for the great ideas here.

[ziipppp]

Hmm, sorry my link to the imgur picture using the message board Img function didn't work.

Let me try giving you a direct link: http://imgur.com/DiV24

And let me try again with a slightly different link address



Sorry noob here - so not sure quite why I can't get this to do something that I hoped was straightforward.

[lliann]

Im loving it too altho I have no understanding of what the heck it does (how does attaching something to the hard tabs on the shell of the mask affect the seal?

You guys are awesome

[Jay Aitchsee]

ziipppp, I like it. The direction of pull is more forward and it doesn't deform the cushion. Mine deforms the cushion a little and I was concerned about it, but, if anything, it makes the seal around the bridge of the nose a little better (maybe). For now, I'm going to stick with the rubberband.

LLiann, just to be clear, this thread is talking about leaks between the cushion and the frame caused by the cushion pulling away from the frame. We're not talking about leaks between the cushion and the face. Although with the mask on your face, in the dark, it can be a little difficult to tell the difference.

Jay

[Jay Aitchsee]

bump

[hyperlexis]

This is totally messed up. Why aren't people demanding their money back from Resmed? Rubber bands? What?

If there is some kind of design defect I'd be on the phone with the manufacturer and their local sales rep every day until they shipped me a replacement. The FX is a very expensive mask and if you need to s***-rig some kind of rubber band onto it, then there's something seriously wrong.

These aren't Halloween masks after all. Cosidering you need an Rx for one, this kind of defective product could, and should, even be reported to the FDA.

[woodworkerjunkie]

This is totally messed up. Why aren't people demanding their money back from Resmed? Rubber bands? What?

If there is some kind of design defect I'd be on the phone with the manufacturer and their local sales rep every day until they shipped me a replacement. The FX is a very expensive mask and if you need to s***-rig some kind of rubber band onto it, then there's something seriously wrong.

These aren't Halloween masks after all. Cosidering you need an Rx for one, this kind of defective product could, and should, even be reported to the FDA.

It could be that "this is the real world", since it is so hard to find a mask that fits and works the way it should. A lot of people are willing to work around problems, when they find a mask that is comfortable to them. You have to realize that some people have spent thousands of dollars on mask, trying to find the mask that will actually seal and is comfortable enough to wear all night. You will find threads on just about all mask, where people are making tweaks to get the optimal fit and to control leaks. If we reported all mask that had problems to the FDA, there wouldn't be many mask out there without a report called in on them! I'm sure that since they (Resmed) are aware of the problem, they are probably working on a solution to address the situation. If not, the mask will get a bad reputation and will eventually disappear from the market.

[hyperlexis]

This is totally messed up. Why aren't people demanding their money back from Resmed? Rubber bands? What?

If there is some kind of design defect I'd be on the phone with the manufacturer and their local sales rep every day until they shipped me a replacement. The FX is a very expensive mask and if you need to s***-rig some kind of rubber band onto it, then there's something seriously wrong.

These aren't Halloween masks after all. Cosidering you need an Rx for one, this kind of defective product could, and should, even be reported to the FDA.

It could be that "this is the real world", since it is so hard to find a mask that fits and works the way it should. A lot of people are willing to work around problems, when they find a mask that is comfortable to them. You have to realize that some people have spent thousands of dollars on mask, trying to find the mask that will actually seal and is comfortable enough to wear all night. You will find threads on just about all mask, where people are making tweaks to get the optimal fit and to control leaks. If we reported all mask that had problems to the FDA, there wouldn't be many mask out there without a report called in on them! I'm sure that since they (Resmed) are aware of the problem, they are probably working on a solution to address the situation. If not, the mask will get a bad reputation and will eventually disappear from the market.

Um, no. This is a medical device. Like a pacemaker, or a heart valve or a replacement knee. If there is a defect it SHOULD be reported to the manufacturer or the FDA. If a medical device company sells something in the USA with a design defect, absolutely that fact should be reported -- so it can be fixed!

If your Ford had a defective airbag design, would you keep your mouth shut and jury rig your own fix just so that Ford's profits wouldn't be hurt by doing a recall? You actually think Ford wouldn't keep making cars?

Hell no, sir. These DME companies MUST hear from patients about real-world problems and concerns with their products (and compliments too!), otherwise they will not improve their designs for the better. And if it means reporting a serious defect to the FDA to prompt a design fix, why would you not do so? If a company sold you tainted medication, would you keep quiet for fear that no other company would make drugs? Please.

I pick up my Quattro FX from my DME today. (Ditching the Amara). I'll do a review of my experiences with the mask very soon..... And if the seal has the design defect people here have reported on, you better believe Resmed will hear about it.

[woodworkerjunkie]

I'm not saying people should not report the problems! I'm saying people like the mask and have found a way to make it work so that they can continue to use it, until there is a fix by Resmed. Like I stated, look through the forums at all the mask that people are making tweaks and adjustments to. People are swapping headgear from one mask to another, cutting and altering headbands, adding additional straps, etc... Peoples head shapes and facial features are all different, so one mask will not fit all. Lots of FFM claim to be comfortable on the bridge of the nose, but, you see people on here posting about having sores from these mask every day.
I don't own nor have I used this mask, though I'm interested in trying one sometime. It could be (not saying it is the problem) that people are over tightening the mask and that could be causing the problem. It could be that the shape of their face causes undue strain on certain parts of the mask and causes the insert to pop out. Not everyone using this mask is having that problem. If any medical device is not used properly it can cause the device to not work properly. You can't just assume that because a few are having a problem that the device is defective. It may be that, that particular device may not work for that person due to facial or head shape and they will have to find another mask, better fit for there face, head, etc...
Several of the new mask, have a double membrane that uses air pressure to inflate and help seal the mask. It is meant to be worn loosely and let the balloon effect work to make the seal. But, I see a lot of post about no matter how hard they pull the straps, they can't get it to stop leaking. That's the problem, they are over tightening the straps and causing the leaks! Doesn't mean the mask is defective.
Since you like to give scenarios: You buy a new Lexus and drive it around at just below redline RPM's and the engine blows after only 20,000 miles. So you get on the net and tell people not to buy a Lexus cause their engines don't hold up, but, you fail to mention that you were running the engine at near redline conditions, Does that mean it was a defective engine, and that Lexus should cover it under warranty. No! Why? Because you were not using the product properly!
All I'm trying to say is, that since you nor I, know the conditions being used to use these mask, we can't say for sure that it's a manufacturer's defect. Only the people in actual use of the mask know for sure! And some of those people may not be reporting all the pertinent information needed to make that decision. So don't be so quick to jump on the wagon to go file a lawsuit or file reports to Consumer affairs or FDA or anyone else, unless you know "all" the facts! The use of any medical device is subjective at best, what one person considers normal use may not be normal according to the design and intent of the manufacturer. There are videos all over the net about how to properly put the mask on and adjust the mask. "Still", you see people come onto this forum complaining about the mask leaking. Then after several post, they come back and say that they have finally got the leaks under control, once they learned how to properly put the mask on. The manufacturers put the info out there, but a lot of people just ignore it or never look at it.
If the end user is tightening the mask to tight, it could be causing the insert to pop out, due to undue pressure on the insert. I'm not saying they are, I'm not there to see how they are wearing the mask. But, it's like a bolt, it has a certain amount of torque it can withstand, after that amount of torque is surpassed, it breaks! And if the mask is meant to be worn loosely, and they over tighten it, something gives, the insert pops out!

[hyperlexis]

I'm not saying people should not report the problems! I'm saying people like the mask and have found a way to make it work so that they can continue to use it, until there is a fix by Resmed. Like I stated, look through the forums at all the mask that people are making tweaks and adjustments to. People are swapping headgear from one mask to another, cutting and altering headbands, adding additional straps, etc... Peoples head shapes and facial features are all different, so one mask will not fit all. Lots of FFM claim to be comfortable on the bridge of the nose, but, you see people on here posting about having sores from these mask every day.
I don't own nor have I used this mask, though I'm interested in trying one sometime. It could be (not saying it is the problem) that people are over tightening the mask and that could be causing the problem. It could be that the shape of their face causes undue strain on certain parts of the mask and causes the insert to pop out. Not everyone using this mask is having that problem. If any medical device is not used properly it can cause the device to not work properly. You can't just assume that because a few are having a problem that the device is defective. It may be that, that particular device may not work for that person due to facial or head shape and they will have to find another mask, better fit for there face, head, etc...
Several of the new mask, have a double membrane that uses air pressure to inflate and help seal the mask. It is meant to be worn loosely and let the balloon effect work to make the seal. But, I see a lot of post about no matter how hard they pull the straps, they can't get it to stop leaking. That's the problem, they are over tightening the straps and causing the leaks! Doesn't mean the mask is defective.
Since you like to give scenarios: You buy a new Lexus and drive it around at just below redline RPM's and the engine blows after only 20,000 miles. So you get on the net and tell people not to buy a Lexus cause their engines don't hold up, but, you fail to mention that you were running the engine at near redline conditions, Does that mean it was a defective engine, and that Lexus should cover it under warranty. No! Why? Because you were not using the product properly!
All I'm trying to say is, that since you nor I, know the conditions being used to use these mask, we can't say for sure that it's a manufacturer's defect. Only the people in actual use of the mask know for sure! And some of those people may not be reporting all the pertinent information needed to make that decision. So don't be so quick to jump on the wagon to go file a lawsuit or file reports to Consumer affairs or FDA or anyone else, unless you know "all" the facts! The use of any medical device is subjective at best, what one person considers normal use may not be normal according to the design and intent of the manufacturer. There are videos all over the net about how to properly put the mask on and adjust the mask. "Still", you see people come onto this forum complaining about the mask leaking. Then after several post, they come back and say that they have finally got the leaks under control, once they learned how to properly put the mask on. The manufacturers put the info out there, but a lot of people just ignore it or never look at it.
If the end user is tightening the mask to tight, it could be causing the insert to pop out, due to undue pressure on the insert. I'm not saying they are, I'm not there to see how they are wearing the mask. But, it's like a bolt, it has a certain amount of torque it can withstand, after that amount of torque is surpassed, it breaks! And if the mask is meant to be worn loosely, and they over tighten it, something gives, the insert pops out!

I think what people have complained of with the QFX is that the 'cushion' is improperly and unexpectedly separating from the hard plastic shell of the mask, during sleep, causing severe leaks and adversely affecting pressures, and hence, treatment. It is an issue with the flange or 'groove' where the cushion is wedged into the mask frame. If you believe the posters, and I have no reason to doubt them, they have treated the masks appropriately, and inserted the cushions as directed, but the cushions keep becoming dislodged. I doubt these people are so inept they have failed to read every line of instructions. And yet still they experience these problems.

If so, then yes, this definitely seems like a design problem that should be reported, investigated and fixed by Resmed.

The QFX is one of the most popular, if not the most popular FFMs without forehead supports, out there. I am sure Resmed will be glad to fix any problems, rather than abandon the entire line. Every product gets updated with time, and as bugs are found. This should be no different. And still, this is a medical device and therefore demands far greater scrutiny and precision than other products. Defects like this should not be tolerated and should be reported to the Mfg., and if nothing is done, than to others. So far, Resmed has not helped these people.

[greatunclebill]

so, how many people have reported their problem in writing to resmed and what was the reply? lets see scans of the replies and not just opinions about they wouldn't help.

i do own and use a quattro fx every night. my mask was fine when new. as it's getting older and more flexible i see the cushion coming away from the frame when it is not on my face. i simply stick it back in the track and put it on and all is well. the only way it will separate at night is if i spring a leak between the cushion and my face and start adjusting. if i pull it too far from my face with the air blowing trying to reposition it, the cushion may drag on my face and leverage the cushion out of the track. i can only recall one time it has popped out like this. if done carefully it does not pop out. if i tugged at it or repositioned it in my sleep i guess it could come apart and i could say it comes apart on its own, because i wouldn't be aware that i had done it. my answer to this is to not report it, because resmed must already know. my answer is that i need a new cushion because they should be replaced every few months anyways. to be sure, this cushion is not as sturdy in the frame as the other masks i have had, but i wouldn't call it a defect.

[chunkyfrog]

When I trialed the QFX, this problem was evident from the get-go (no wear involved unless it was a USED mask.)
(now that I think of it, the DME had already opened the packaging--these particular guys are extreme sleazeballs)
I am kind of relieved that the POS in question simply did not fit me--as I might have been tempted to make it work otherwise.
You guys' ingenuity impresses me very much!

[woodworkerjunkie]

I pick up my Quattro FX from my DME today. (Ditching the Amara). I'll do a review of my experiences with the mask very soon..... And if the seal has the design defect people here have reported on, you better believe Resmed will hear about it.

These aren't Halloween masks after all. Cosidering you need an Rx for one, this kind of defective product could, and should, even be reported to the FDA.

Since you "know" going in of the "known defects", it makes me question "why" you would even want such a defective mask? Surely your not one of those people trying to find a reason to complain or possibly file a lawsuit! If I honestly thought a product was defective, I know I wouldn't buy it or waist my time trying it! It doesn't make since for you to tell people the mask is defective and that they need to report it to anybody and everybody, but yet, turn around and say that your going "today" to pick up that very same mask! I have to ask; have you bought a hot cup of coffee from (insert your favorite restaurant) lately? If so, did you expect it to be hot or warm, so that it wouldn't burn you? Cause it sounds like to me, your going into purchasing this mask, expecting it to burn you!

[hyperlexis]

Well -- I just picked up my QFX about an hour ago. I'll post this review separately too.

First impressions: Extremely comfortable, even sensual mask cushion. OMG its borderline sexual..... (can you even say that about a CPAP mask?). Think goose down vs. polyester.... Those Australian engineers really have something here! It's truly magnificent on the face and the nose support is very well designed -- it squeezes the sides of the nose, not the bridge itself -- the actual support at the bridge of the nose is left open, like a "U". Only the outer air seal contacts the bridge. Hopefully this will end the redness and pain my nose bridge has experienced using my trial Amara mask. For the comfort of the cushion alone I would recommend this mask, or its similar, older sibling the Mirage Quattro.

Second impression. The lower corner of the cushion was poking out of the seating channel! Ha! Loose straight from the factory.

Fitting the soft silicone cushion into the channel of the hard outer mask shell does appear to me to be a definite design problem with the QFX. Press fitting the whole cushion into the channel requires concentration and care, especially if you have nails. Very easy to miss a spot if you are not careful and/or nick the cushion. The Amara and the regular Mirage Quattro have much better designs -- either the mask cushion is attached directly to to the hard mask shell and can be popped out as one unit for washing or replacement (Amara), or the cushion has a separate hard perimeter frame that is popped in and out of the mask shell with clips (Mirage Quattro). Resmed could, and should adopt one of these designs for the QFX.

The current cushion design is liable to loosen up and fail when the outer hard mask shell warps with use, or when the cushion becomes deformed with age and use. And it will get serious use -- you really have to manhandle the cushion to press fit it into the channel in the mask shell. And this includes daily disassembly and washing as per ResMed's use instructions. That's a lot of stress on a delicate item that other masks with different cushion designs don't have to endure. With the QFX you are essentially removing, washing, and reinstalling a delicate silicone gasket -- every single day. That's a lot of wear and tear.

In terms of FF mask ease of cleaning, the Amara is far easier to clean and reassemble, as is the FullLife, and the V2 Hans Rudolph -- they have integrated mask shells and cushions. The Mirage Quattro is also likely easier to clean than the QFX because it has a cushion frame with clips. I'm sure there are other similar, more user friendly designs out there from other manufacturers as well. However any mask like the QFX, requiring daily removal/reseating of a silicone cushion into a narrow sealing channel is going to be a problem and subject the cushion to unnecessary wear and tear. No wonder they are popping out of the QFX. So either the cushion, and/or the mask shell will need replacement on a more frequent basis compared to other FFMs with better cushion designs.

Oh, the price we must pay for comfort.... Vanity, vanity.

[hyperlexis]

I pick up my Quattro FX from my DME today. (Ditching the Amara). I'll do a review of my experiences with the mask very soon..... And if the seal has the design defect people here have reported on, you better believe Resmed will hear about it.

These aren't Halloween masks after all. Cosidering you need an Rx for one, this kind of defective product could, and should, even be reported to the FDA.

Since you "know" going in of the "known defects", it makes me question "why" you would even want such a defective mask? Surely your not one of those people trying to find a reason to complain or possibly file a lawsuit! If I honestly thought a product was defective, I know I wouldn't buy it or waist my time trying it! It doesn't make since for you to tell people the mask is defective and that they need to report it to anybody and everybody, but yet, turn around and say that your going "today" to pick up that very same mask! I have to ask; have you bought a hot cup of coffee from (insert your favorite restaurant) lately? If so, did you expect it to be hot or warm, so that it wouldn't burn you? Cause it sounds like to me, your going into purchasing this mask, expecting it to burn you!

No wise guy. I ordered it weeks ago but the dumbass DMEs I have to deal with didn't get it in until today. They stuck me with another mask during the interim period. And no, I do like the mask (on first use) -- but I can still look past the end of my nose and see that it has a problem prone gasket design.