BROKEN RESPIRONICS COMFORTGEL MASK? REPORT IT!

Are you tired of reading complaints by users whose Respironics ComfortGel Masks break?
On these forums are temp fixes out of duct tape, epoxy glue, and drilled holes and wires.
Why do we put up with this absurd problem by a large medical equipment company?
Do something besides duct tape. Here is how!

Medical devices are not supposed to break during use. When mine did for the second time,
simply breaking from me rolling my head in my sleep, I awoke gagging for air. This is an
intolerable situation that can be life-threatening. (OSA by itself is life-threatening;
we don't need poorly-made CPAP equipment to assist our demise.)

Respironics offers a 90 day warranty on their ComfortGel CPAP. Beyond that, I was out of luck!
Respironics told me to contact my medical supplier. And be told the product is out of warranty?
I had owned the mask for 6 months.

This is a medical device. It is regulated by the FDA's Department of Health and Human Services MEDWATCH. So, I complained to the Government's MEDWATCH website, filled out the Product
Problem Form, provided the Respironics Model Number, and details of it's failure.
I recommend checking the 'Life-Threatening' Box.

It is a defective product, sold at outrageous mark-ups, intended for medical use, and manufactured
in China. (Medical devices are not the jurisdiction of the Consumer Product Safety Commission.)

Be aware that Respironic-Philips is no stranger to product failures. A current Government
recall is underway for a defective Respironics device meant for young children.
Now THAT'S SCARY!

Just for good measure, send a copy of your FDA Recall request to Respironics Customer Service.
I received a 'thank you' from FDA's MEDWATCH that noted if more complaints are received,
they will get involved. FYI, nothing was heard back from Respironics.

Dave Davis
St. Louis, MO

Right on Dave! theses masks are absolute junk, yet one of the most comfortable out here. I have a fine collection (5) of broken ones. I've contacted Respironics a number of times and they claim they are not aware of any issues caused by defects. They claim it's the way the users remove the mask by pulling of the mask without disconnecting it. BS! I have never just pulled it off. It is a clear design flaw which most suppliers are aware of yet Respironics continues to deny it. I've talked to a number of suppliers that have attended Respironics sales meetings. When the issue of premature failure comes up in a question session the lairs )(salesmen) deny of any knowledge. If anyone is interested the, CEOs email address can be found online if you do some digging. Cpaptalk will not allow me to post it. I find that rather strange...
Maybe Mail dot Spence(at) respironics dot com will work. He's the CEO.

You are not getting much response to your post...either there are not very many that have had this problem..or..noone cares. I personally have been using this mask for 9 months and have had no problems. By the way Dave and Fritz...why arn't you registered users ??? or...are you the same person?

Dave you've made numerous posts on this. Others (including myself) have already answered.

Try adding a link to the FDA to get more people to involved.

Recently, it was reported that Respironics redesigned the Comfort Gel and there is a new version of that mask that addresses the breaking clip issue.

These masks tend to break on those with larger heads. The sockets aren't designed to hold all that tension.

*sighs*

Dave, while I'm sure that you've had problems, as I stated in another post regarding this problem, Respironics does know about this. Despite what you may have been told or what others might have been told. If it breaks within the 90 day warranty period, your DME needs to know so they can send you a new one. The warranty is to take care of manufacturer defects.

Mine broke and I wear a petite. It was less than 30 days old. It was replaced. I will stay with Respironics ComfortGel until they take it off the market.

sleepyinstlouis wrote:*sighs*

Dave, while I'm sure that you've had problems, as I stated in another post regarding this problem, Respironics does know about this. Despite what you may have been told or what others might have been told. If it breaks within the 90 day warranty period, your DME needs to know so they can send you a new one. The warranty is to take care of manufacturer defects.

Mine broke and I wear a petite. It was less than 30 days old. It was replaced. I will stay with Respironics ComfortGel until they take it off the market.

Like wise for me I use what works for me. I just make sure and put the Bull out of me China Shop, before I go to bed. A little TLC and the mask doesn't break (MUCH) when it does there's Epoxy. Rule one, have spares of everything. Jim

CG's are not the only Respironics masks to break - I've found the Comfort Selects routinely fall apart too, and I only use them now (they're nasal masks but fit me well), with taping, as back-ups when I can't use my UM FFM, but half have got duct tape and who knows what holding them together.

LSAT, no Dave and are are actually two different pwople who believe that medical devices should last and not continually cost you money. Actually any simpleton that Goolgles Comfort Gell issues,mask problem,broken will find a litany of hits regarding this issue.
With regards to the posts concerning duct tape, epoxy or Cyanoacrylate addhesives to repair them is is proposterous.
If you by a new car and the door keeps opening while you are driving, would you simply use a hanger to keep it closed?
I suspect not, most people would be sreaming bloody murder and reporting it to the NTSB.
So why should this be any different?
As I stated in my previous post this is a terrific mask with exception to the mounting issue that has been around since these masks were first recalled back in 2003 for exhalation issues.
www (dot) copd-international(dot) com/Library/ComfortGel_mask_recall(dot)htm

For those of you who can afford to replace these masks every six months or so, there is no longer any need for you to continue reading.

For those of you who can't, below is the URL for the MEDwatch form to report this defect to the FDA.
I completed the form in about ten minutes and submitted mine last night.
www(dot)fda(dot)gov/Safety/MedWatch/HowToReport/DownloadForms/default(dot)htm
If you don't take the time to do so this will never get fixed.

I also have a Fisher Paykel HS405 that has lasted long enough for me to actually order replacement pads. This is comparable
to the Comfort Gel mask but apt to moisure build up that can be an annoyance.

I suspect the socket issue is seen not only in the ComfortGel but also the ComfortSelect and the Comfort fusion.

Fritz7 wrote: If you by a new car and the door keeps opening while you are driving, would you simply use a hanger to keep it closed?

No, I have found it rattles too much, so I use Duct Tape, I tried Crazy Glue on the right door, it worked but I can't get it open. The wife has to get in on my side and slide over.

You forgot to mention the other problem with the Comfort Masks, the Forehead "T" Pad also breaks, I haven't found a worthwhile repair for that, so I always save the broken masks for parts. Actually the Tab Ears breaking off is useful as it keeps me supplied with "T" Pads.

respironics has known for years that the comfortgell hook up design is bad and has done nothing, Ive broken several, including one where I deliberately reduced the strain of the elastic as much as I could

a local CPAP supplier no longer sells their products

I've had my ComfortGel Full since Sept 15 08. The adjustment prongs have slowly broke off two by two and now I can't adjust it to fit at all. Respironics website conveniently has their warranty section "down", and there contact page malfunctioning as well.

I called my supplier in the middle of the night and I hoping they'll be able to help me. I'm waiting for a call back right now.

Other than the adjustment issues, it is a great mask. I'd hate to see it pulled from the market, because it is very comfortable. However, the safety, design, functionality, and weakness of plastic does need a lot of improvement!

The only thing great about this mask is the COMFORT!

Really upset.

I've used a cpap for 3+ years, probably 2 1/2 using the comfort gel. I've gone through at least 6. They always break at the connection and just after the warranty period. It wasn't so bad when I could order online and pay 50 some bucks. I went in to the doc in April of this year, had them give me one and the bill was $377.00!!!!! Now it's broken again. Currently using one I drilled a hole in and wired the black plastic swivel clamp to the mask. It's leaking like crazy but better than nothing.

I will follow up with the complaint.

I'm in the same boat here. I really like the way the comfort gel fits and works, but it always breaks. I keep twist ties in my bedside drawer in anticipation of this inevitable problem. I've been through three in three years. I came on this site tonight in hopes of finding a better alternative mask.

ran wrote:It wasn't so bad when I could order online and pay 50 some bucks. I went in to the doc in April of this year, had them give me one and the bill was $377.00!!!!!

Not doubting you, just don't understand what you're saying. Why is it that you USED to be able to buy one online for $50...and no longer can? I still see them online at several sites for not much more than that. Why did you pay $377 through a doc instead???