Hello Guest, Welcome to Apnea Board !
As a guest, you are limited to certain areas of the board and there are some features you can't use.
To post a message, you must create a free account using a valid email address.

or Create an Account


New Posts   Today's Posts

EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
#91
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
Wow...I'm glad I read this lengthy thread. I've used the P10 almost exclusively for the last three years. I've tried Dreamwear, but nothing compares to the comfort of the P10, IMHO.

A few months ago, I had sinus surgery and was not able to use CPAP for a short while until I healed. When I resumed therapy, I was quite dismayed to find that I could no longer tolerate the P10. Other masks were fine...but when I used the P10, I would awaken shortly after going to sleep gasping for air. I had no idea what the problem was. This was in October...moving into colder weather. I had also recently began to use a heated tube with a cover to minimize rainout. I was surprised to find that I still had issues with water condensation, even on lower settings. It seems to be even worse on nights that were not so cool and I would have a fan blowing towards my side of the bed. Even with the heated tube and cover, I'd wake up with water dripping down my face.

I had no idea that the two issues...the condensation and my gasping for breath...might be related. Now I see that water might be blocking my vents, even on nights when I might not experience rainout...and of course, that I may have dust buildup that needs to be cleaned.

Everything makes sense now. Thank you so much for this research.
Post Reply Post Reply



Donate to Apnea Board  
#92
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
mdmarmd, impressive scientific research!
Post Reply Post Reply
#93
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
I have been suspicious of the vents on the P10 from the first time that I used it right after cleaning.  The vents can become completely obstructed by water alone.  If you clean the thing, the ports become completely blocked until the water dries.  The water will dry after a few minutes of use.  However, it you experience a rain-out condition, this could conceivably clog the ports after you've fallen asleep.  

The Swift FX is a considerably better mask.  Because the back is soft, it conforms better to noses.  It's perhaps slightly heavier, but I don't think that's a real issue.  The other benefit of the Swift FX is that it uses traditional holes as ports, and not a mesh system.  I clean my mask with detergent every night, and rinse my hose and chamber every night as well, and never noticed so much as discoloration on any of them.

IMHO- Every CPAP users should occasionally sleep with a recording pulse oximeter to measure how their treatment is going.

I've sent the OP a PM with the email address for ResMed's Chief Medical Officer as well as an offer to assist him in getting ResMed's attention on this.
Post Reply Post Reply
#94
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
Hi there, I'm new to this board and I came looking for information about a problem I've been having with my P10 mask, which is exactly as described in this thread. I really want to say thank you SO much to mdmarmd and all the other users who have joined in with their info.

I have reported this issue to my doctor and doctor's technicians but their response was rather dismissive. They didn't mention cleaning or condensation -- the attitude was basically "the machine says everything is fine so you must be imagining things". I suggested that it might be my own nasal congestion increasing over the night (I am on antihistamine to help with poor nasal patency and on the waiting list to see an ENT), and they thought that might be one explanation but took it no further. I haven't thought of reporting it to ResMed because I tried to report a previous issue (big water leaks from the humidifier, which seemed to be improperly sealed) and had no useful response.

I also happened to be talking with a new friend about CPAP and we discovered we both had the same mask and the same problem, which she had not reported to her doctor as she assumed it was part of her process of adjusting to CPAP in general. So I agree with earlier posts to the effect that this is likely to be an under-reported issue, and even once reported, there are clear incentives at every level in the system for sweeping it under the carpet. And I also agree that not seeing major cases in the courts doesn't mean there isn't a real problem.

I wonder if anyone can shed light on the issue that actually prompted me to report this to my doctor? In the course of my CPAP trial I have used 3 different machines and multiple masks. I know at the start whenever I took off the mask to go to the toilet or similar without turning off the machine, it automatically switched off after a few seconds of not being attached to a human. At some point, whether it was as soon as I switched to the P10 or after a period of use, I am not too sure, this stopped happening. Nowadays the machine is not shutting off -- it keeps running as if there were still a breathing human attached, for upwards of 2 minutes (at which point I usually reattach myself -- I have never seen it switch itself off). I took note of the times this happened over a few nights, and together with the supplier's technician we looked at the data, and no increased leak was being detected by the machine during these periods. We swapped around machines (same and different brands) and masks and discovered that the problem was specific to the P10. We checked the settings and they were correct. It was definitely the particular mask.

At the time we didn't think to check the filter at the vent.

Do you think this failure to register a leak and shut off is related to the problem discussed in this thread, or could it be a separate issue? I'm too sleep-deprived (CO2 poisoned??) to think it through logically right now!

Either way, it really bothers me -- if the machine can't tell if I'm even attached to it, how can its data on anything be reliable? How can it be adjusting pressure appropriately, measuring AHI etc if it doesn't register being totally removed from my face?? I feel like this machine is just moving air around and telling a nice little data story about how effective it's being, so that I will keep feeding it $$$.

I guess I'm going back to a less comfortable mask, but what a shame.

Night night.
Post Reply Post Reply



Donate to Apnea Board  
#95
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
I think I was too late to edit my previous post, sorry. Just want to clarify that I am definitely experiencing the suffocating sensations described by others, as well as the non-detection of leak when mask is removed. And the suffocation episodes became noticeable after a period of use without more than a cursory clean, but which also happened to coincide with cooler weather.

And I've now looked at my vent. It's pretty dirty, but as we get fairly sudden and unpredictable changes in overnight temperature and humidity where I live, I find it's pretty hard to prevent condensation ever happening, and given that it seems you can sleep through a pretty bad rebreathing of CO2 episode, I still think that if I end up buying one of these masks I will be sticking pins through it to protect my remaining brain cells.
Post Reply Post Reply
#96
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
Canberragirl wrote:

At some point, whether it was as soon as I switched to the P10 or after a period of use, I am not too sure, this stopped happening. Nowadays the machine is not shutting off -- it keeps running as if there were still a breathing human attached, for upwards of 2 minutes (at which point I usually reattach myself -- I have never seen it switch itself off).

This feature can be implemented using the SmartStart feature but it must be done in the clinician mode. Did you or your provider enter this mode before you lost this function?

   
Post Reply Post Reply
#97
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
ResMed makes clear that the SmartStart feature may not work with pillows and pressure less than 7.0.  Others report it not working with pressures greater than 7.  It is a known issue.  See:

http://www.apneaboard.com/forums/Thread-...al-pillows

                 and

http://www.apneaboard.com/forums/Thread-...-Shut-Down
Coffee

Happy Pappin'
Never Give In, Never Give Up




INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. 
Post Reply Post Reply



Donate to Apnea Board  
#98
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
Yes mdmarmd, the technician and I adjusted SmartStart and unless we both made a mistake, it is on the correct setting to turn off automatically. But as I'm a noob I will double check. Thanks very much for your comment.

Thanks also sonicboom for your reply. My pressure is 8-12 and there is no ramp so it shouldn't ever be going down to 7. I didn't realise there was a thread about the problem also showing up at higher pressures -- sorry for not doing my homework on the board. I'll forward the info to my technician and doctor's office as none of them had heard of this issue or had any suggestions.

Much appreciated.
Post Reply Post Reply
#99
RE: EVIDENCE OF AIRFIT P10 VENT OBSTRUCTION CAUSING HYPERCAPNIA
FDA MEDWATCH REPORTING:

Canberragirl  wrote:

I have reported this issue to my doctor and doctor's technicians but their response was rather dismissive. They didn't mention cleaning or condensation -- the attitude was basically "the machine says everything is fine so you must be imagining things". I suggested that it might be my own nasal congestion increasing over the night (I am on antihistamine to help with poor nasal patency and on the waiting list to see an ENT), and they thought that might be one explanation but took it no further. I haven't thought of reporting it to ResMed because I tried to report a previous issue (big water leaks from the humidifier, which seemed to be improperly sealed) and had no useful response.

I also happened to be talking with a new friend about CPAP and we discovered we both had the same mask and the same problem, which she had not reported to her doctor as she assumed it was part of her process of adjusting to CPAP in general. So I agree with earlier posts to the effect that this is likely to be an under-reported issue, and even once reported, there are clear incentives at every level in the system for sweeping it under the carpet. And I also agree that not seeing major cases in the courts doesn't mean there isn't a real problem.

 
Canberragirl,

You might consider submitting a MedWatch report to the FDA. You can either download the MedWatch form from:
 https://www.fda.gov/media/76299/download

Or you can use the online process:
https://www.accessdata.fda.gov/scripts/m...reporting1

The reports are anonymous and would not require a lot of detail beyond documenting that the P10 vents obstruct with water, dust or both.

In March 2019 I spoke with a professor of sleep medicine at Harvard Medical School after he had reviewed the report I had prepared to submit to the FDA.  He said it was an interesting observation and even said he could submit it directly to ResMed as he knows people there.  But I said I’d rather submit it to the FDA because I felt that, without the weight of a regulatory agency, ResMed would have little incentive to investigate this concern.  He did say that the FDA would never act on the basis of a single report and he encouraged me to get others to submit reports as well.

I submitted my report and it was received by the FDA on March 22, 2019:
https://www.accessdata.fda.gov/scripts/c...101&pc=BZD

I got a confirmation letter on April 25th.
   

Of note, a search of the FDA MAUDE (Manufacturer and User Facility Device Experience) database reveals that there has been only one report submitted in the five years since the AirFit P10 was launched--at that was mine.

I know from reading the threads here and in the other apnea forum that there are quite a number of individuals, like yourself, who have raised concerns but no one has submitted reports.

Unfortunately, if there are not additional reports, I doubt the FDA will ever look into this matter.
Post Reply Post Reply


Possibly Related Threads...
Thread Author Replies Views Last Post
  Whistling noise through the vent holes Slugger 4 199 05-15-2019, 03:39 PM
Last Post: 3rdMarDiv
  [Equipment] Mask adaptation or oxygen bleed in causing readout errors? KallyA 13 261 05-12-2019, 08:33 PM
Last Post: KallyA
  has anyone tried the new Resmed Airfit P30i? sherryl10 4 336 04-25-2019, 12:26 PM
Last Post: edfreeman
Video Airfit P30i Youtube Hihowrya 4 391 04-16-2019, 08:58 PM
Last Post: pabmd
  Resmed Airfit F30: Only one frame size? UncollapseMeThroat 24 754 04-11-2019, 05:49 PM
Last Post: Big Guy
  What's the longest you've worn an AirTouch or AirFit cushion? Lanco 8 326 04-10-2019, 06:03 PM
Last Post: car54
  My AirFit F30 complete mask arrived today. Big Guy 8 387 04-04-2019, 10:37 AM
Last Post: Big Guy


New Posts   Today's Posts






About Apnea Board

Apnea Board is an educational web site designed to empower Sleep Apnea patients.