ejbpesca

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

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.

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?

Thank you for the help. I will let go for now of my recent obsession with events flagged during Large Leaks. What I consider bizarre is how during LL sessions 70 OA events can register over 30 minutes. That is suffocation, and I don't think it is accurate.

If my machine is set to past 10 cm pressure no full face mask will stay sealed on me. I call it a blowout when a seal cannot be made. By week two on a new mask cushion, I have to cinch straps tighter and tighter to keep leaks down. It becomes painful.

Using APAP I have recurring themes of pressure up leaks up and leaks up pressure up. I tried straight CPAP @ 8 cm and had the worst AHI ever... 17.00 so back to APAP.

I raised my Min. pressure to 9.4 cm using my new F40 mask. Flow limitations went down but the rise in CAs caused an unusually high AHI yet I think therapy went better than usual. Two rested days in a row with my new F40 mask is very impressive. Leaks went up, AHI went up, but I felt more rested than I have in years. Finally, maybe a mask that somewhat works.

CPAP therapy has been very disappointing for me for over 17 years. I see a doctor once a year. Nothing is checked or disgusted. It was just last year my compliance was verified. For 14 years I complied with therapy even though it never made me feel any better. I am sure I am not alone. With time to get into the nit and grit of OSCAR reports over the past couple of years, I just may be on the verge of effective therapy. If it were not for online volunteers like you I would have no guidance...AT ALL.

Maybe someday CPAP machines and OSCAR will be at a higher AI level and be able to fine-tune therapy on the fly.

My next quest is to copy/paste my OSCAR Statistics to a spreadsheet and then produce line graphs from the data. The bar graphs of OSCAR Overview are too busy for me to track trends. It is a sort of "can't see the forest for the trees," effect I get from staring at those bar graphs.

Best of luck to you and your wife. ejb

Sierra wrote: "For apnea events for sure, it stops trying to classify apnea events when the leakage rate exceeds 24 L/min. I am assuming the same may apply to hypopnea events. In other words they are not likely false, and are there during high leakage but are not being reported. "

OSCAR can show events with a code of H, CA, AU, or OA during gray, over the red line periods that exceed 24/L min. Would those not be false events (with classification) due to the machine not functioning properly during the over 24 L/min. perioid? I will research more to see if waveforms and/or lack of them match the event classifications shown in over red line sessions.

If the machine has lost its ability to function due to an over the red line 24 L/min. limit, how can the Hs, OAs, AUs, and CAs, flagged during that time be accurate? This is the basis of my theory that AHI is skewed by Large Leaks. During a Large Leak over 24 L/min limit, events are being counted in with the rest of the events of the sleep period. These flagged false events can produce an incorrect AHI, possibly way off the true AHI.

I suspect I have AHIs that if corrected for false events would be up to 50%+ less than the index shown.

I see what you mean. The pressure and flow limitations follow a similar path. Thanks. I have the machine on EPR 3 now. I will increase my Min. pressure to try to get flow limitation down. Is that not a tactic to reduce FL? I rarely go over 5.0 AHI so I may be out of luck on getting BPAP covered by insurance. There is a possibility that my FLs are not treatable by any PAP machine. My airways are chronically clogged. I have FLs awake or asleep. I will mention an AirCurve next doc visit. Sierra wrote: "I kind of think those hypopnea events are sneaking in when the leakage drops below the leak rate redline for brief periods of time."

A brief leakage drop below the leak rate redline lasted 14 seconds. 2 minutes and 30 seconds later, a hypopnea was flagged. In 1 minute 20 seconds, another hypopnea was flagged. In 30 seconds another hypopnea is flagged. The breath shapes near the H flaggings look the same as many breath shapes with no flags.

By "sneaking in," do you think these hypopneas could be false flags? My point about this issue is that I think AHIs may be inaccurate due to false flagging of events that I especially notice within gray areas. I have seen it demonstrated on video how machines or OSCAR can miss flagging events. I am saying events get flagged that did not exist, and I think the hypopneas I describe above are examples. I theorize that when the leak rate goes high enough the system malfunctions because it takes a good steady mask seal to produce a more accurate AHI. I am not concerned about my machine or OSCAR missing a few OA/CA/Hs. I think I may need to make the decision to stop fretting over AHIs of 2.00 - 5.00 and realize my air flow limitations...literally.

I wonder if the data that comes from CPAP machines have a published margin of error (+/-) for AHI. I also wonder if OSCAR has an accuracy margin of error.

Thank you for your attention, consideration, and lending of expertise. My doctor only checks compliance with usage requirements and refills the CPAP prescription annually. Not once in 17 years of CPAP therapy has my doctor, DME, or any medical staff looked at any report, asked how therapy is going, or offered advice. ejb

Thanks for taking a look.

I will post the whole screen. It is not the leak that affects AHI, my theory is that during the long leak period, the Hypopneas flagged within the leak event are not correct and it is those events that raise the AHI. If the mask is in such a high state of leaking, how can it be registering genuine hypopneas?

This is an example of what I call a blow out. An OA triggers a pressure increase which may cause me to move. I move, and the mask loses its seal. Mask pressure goes up and first then down as the seal is lost. All graphs on OSCAR shoot up. I theorize therapy has been lost during this LL session, and the flagged Hyponeas are false so AHI is skewed.

I am a veteran of 17 CPAP use on my 5th machine. I am just now learning about the ResPlus machine. Interestingly, the ResPlus has clinical settings readily available. Many patients do not get their machines set properly nor get attention from Dr.s or DMEs as pressure settings need to be changed. I hope you found your pressure settings in the ResPlus menu. A dry nose can be helped by using the humidifier feature. Dry mouth won't be helped by the machine. Some people tape their mouths shut during sleep with Cover Roll or another brand of tape to prevent mouth breathing which is the cause of dry mouth using a full face mask. Bloating due to CPAP is called aerophagia. Reducing the Pressure will reduce aerophagia. Use your SD card to transfer your machine's data to an app called OSCAR and you will see a large amount of data that shows how your therapy is going in great detail. The goal is to use the least amount of pressure that is most comfortable with the lowest AHI. Some use APAP mode, others straight CPAP. I use APAP mode on a ResMed AirSense. Pressures Min. 10 Max 20.

Best of luck, ejbpesca

I give advice only as a fellow CPAP user, not a medical expert.