ResMed A-11 Toxic Odor

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.

My routine in cleaning my AirSense 10 is to rinse the water reservoir hose and mask with pure vinegar. I then add a bit of Dawn dishwashing detergent to the each component and continue to shake and rinse. Last I rinse out the parts with plain warm water until there is no more soap residue. Each night I turn on the pre warming cycle about 15 minutes before going to bed. The only time I have had a bad smell come out of the machine is when I let the reservoir run dry during the night. When that happens I wake up with a dry nose and thinking that something was on fire, or I was breathing out of a gym bag full of unwashed clothes. Not pleasant, but my fault.

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.

If the odor was so toxic, why did you use the machine, as you say, for three days? Also, I just checked the FDA’s MDR database and do not see any complaints listed for such complaints?

My new ResMed AirSense 11 APAP had a strong smell to its output air. The odor was similar to burning insulation from a failing electrical connection. I returned it and got an AirSense 10 that does not produce a smell. My previous AirSense 10 did not have a smell either. One of my early machines did but it was not nearly as strong as what the AirSense 11 produced. This toxic smell issue is one others have also experienced causing them to also return an AirSense 11. Not sure if A11 is the same machine.

I am having the same experience as you.

I too have been using Cpap machines for over two years. I am also a retired homecare provider and dental assistant. I know how to perform the proper maintenance steps as do you.

After 2 years of use my Air Sense 10 machine started emitting an extremely strong toxic smell every night after about 4 hours of use, and yes, I made sure that there was plenty of water in the chamber. I did experiments to try to change the settings to explore the cause of the smell. In the end, I had to buy a new machine because it was extremely dangerous.

The story does not end there. I was sent a new Resmed 11. I washed it and let it run by itself for 8 hours when I first received it, in order to blow out any off gassing. Then I started using it. Everything worked as it should, and I was relieved to finally return to getting some more peaceful sleep. Notice the word,"was".
About the second or third week in, I woke up in the middle of the night with a strong plastic odor. This was a different odor than the first machine, but it was still dangerously toxic. Now after at least two more weeks of testing to try and solve the problem, I too am having to return the machine. Just a note to the readers of this post. If you have not had the problem, then please do not reply! The problem is with the machine itself, there is no fixing it. I am only interested in hearing from others that have had or are having the same problem.
When I first had the problem With my Resmed 10, I found a Remed Facebook page that had at least 20 to 30 complaints just like mine. Unfortunately, Resmed has taken that page down, so what I want to know is how many more of us are out there having problems with toxic fumes???

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.

Reading more about the toxic smell/taste the Airsense 11 can produce, it seems it is present on only some machines or some do not mind the smell. I have heard of returns and returning Airsense 10 but I've not heard of a recall. Many reasons have been given as to what may cause a smell of CPAP air other than the machine itself. None of the suggestions apply to my AirSense 11. The smell came from the inner workings of the device. The smell is similar to substandard-grade plastic that continually emits an offensive chemical odor. I know my AirSense 11 emitted an offensive chemical stink making it unusable. The AirSense 10, like my last one, does not emit the smell. What I do not know is if every AirSense 11 produces the smell or just a few, or if the problem has been addressed. I have not had the AirSense 11 for a year so I am not able to give a serial number to the FDA. How can a complaint be filed for a device that was replaced as most all have done to solve their problem? Complain about a product that was replaced without question as per the policy of DMEs?

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 have not had the unit in my possession in about a year. I cannot find the serial number if I don't have the unit. Filing a complaint about an experience with a product you once owned and was replaced under warranty will not carry much weight. I do not know where the machine was made. Those who have had a bad experience with the AirSense 11 are former owners of the offending product since they mostly got a replacement quickly. The DMEs should be filing information about returns and the defect problem but of course, they do not want to make waves with ResMed.

One person had the gas analyzed and submitted the findings of toxicity to the FDA. That is a valid complaint with substance.

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 FDA Medwatch program is designed to allow both medical professionals and patients to report problems such as this thread has been discussing. It would help other folks if you have had this problem to take the time to file a MedWarch complaint. Often a manufacturer will follow up to replace the unit so they can do their own testing. Good luck https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

I have reported the noxious odor experience I had with the ResMed AirSense 11 to MedWatch.