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I encourage you to file the complaint with as much information as you have. Let them know it was bad enough to be replaced. The more complaints the better chance something will be done about it. The DMEs only care about your $$$ they are not going to report the supplier and risk profits. The one you returned was probably given to another patient.
The Serial Number of the unit should be on the bottom of the unit. File a complaint with the FDA with all the information you have. Like I said in my last post, I believe the smell is more prevalent depending on where the 11 was manufactured. The smell in my opinion comes from the chemical's flashing off from the plastic use to manufacturer the product, kind of like that new car smell from the plastics flashing off in a new car. Anyway inhaling these fumes can't be healthy.
I suggest anyone that has this odor issue with the 11 machine fil a complaint online with the FDA, hopefully the more complaints that are filed the better chance they will look at it. Not sure if this is the problem but my first 11 machine with the real bad odor was made (if I remember correctly) in the Philippines, the second 11 machine was made in Australia/ New Zealand.
I still don't see it, I see points and most of those are 0
Thanks for your input Sierra. I don't believe mine is a cleansiness issue since mine is a new machine. Mine is more like a flashing issue from the plastic or possibly some kind of adhesive or some other substance within the CPAP itself. It's kind of like the new car spell when you get a new car it smells because the plastic is leaching out the chemicals. However The odor from the CPAP is much stronger because it's more concentrated and it forces it into your lungs.
I'm new to this form, and haven't been able to figure out how old a post is or when a post was started. Am I missing something? It sure would be nice to easily know what day a post/thread was started Thanks
New to the forum but not to CPAP. My question is does anyone have a toxic odor when using a new A-11? I got my first A-11 in June, (made in the Philippines) after using it for 3 days I just couldn't use it anymore. The odor was so bad that I got sinus headaches and had chest/lung irritation. Contacted the medical supplier and was told to contact my doctor. Needless to say that with that response I returned the device and no longer use that supplier. I did file an MDR with the FDA and Resmed contacted me wanting me to return the CPAP. I told them they would have to get it from the supplier. Got my second A-11 (made in Australia) and it has the same order (not as bad as the first) but I still wake up with headaches and chest discomfort. I literally have to let the thing run for at least 2 hours before I need to use it to dissipate the odor but the odor is still there and I could smell it during use. It's been over 2 weeks now and I still can't get rid of the odor I contacted Resmed again and they asked me to return it. I asked Resmed what was the result of their investigation into the first CPAP and they told me the supplier said it smelled like smoke and was smoking, they said they tested it and it was fine. I replied to them to reference the MDR it was not smoking it had a toxic odor. Anyway the only thing I can do now is file another MDR with the FDA. My real issue is what is the toxic odor and what is it doing to my lungs. I've actually thinking about throwing the thing in the trash.