I am reporting Resmed and Respironics to FDA Medwatch

[ResmedUser]

If they cannot do better quality control than this, giving me approximate pressures rather than pretty exact pressures, I say screw them. I am reporting both of them to FDA Medwatch for manufacturing, marketing and selling shoddy equipment. I did not have to do anything like this the first 3.5 years I was on CPAP, its a shame I am having to do this now.

http://www.fda.gov/Safety/MedWatch/default.htm

[marcosv]

Please share what (if any) response you get from the FDA over this.

[ResmedUser]

Please share what (if any) response you get from the FDA over this.

Knowing how these medical companies have good lobbyists and such, the answer (if any) will probably be "noted and logged." I am going to file a written complaint, but I aint expecting much.

Mikey

[DreamDiver]

I am reporting both of them to FDA Medwatch for manufacturing, marketing and selling shoddy equipment.

Why not post what you wrote to the FDA here as well?

[tschultz]

Good luck with that!

The problem you have been so vocal about is not about quality control, but rather the specifications. Your own information clearly shows that the pressure is within the specified tolerances and this was pointed out to you a number of times.

Do you realize that the watch you use to tell time most likely is specified to have as much as a 3 minute error over a year. This is an even bigger concern because with that in 20 years you may have an error that can be as much as a whole hour!

Getting back to the CPAP machine, if you truly expect to get a machine that yield "exact pressures" then expect the cost to increase by a factor of at least 50 times, and even then the unit will never be exact, but will instead have specified tolerances to be within the +/-0.1 cmH2O that you seem to be expecting. It may also require costly re-calibration every 90 days or so and can not be moved without voiding the calibration.

I for one hope they continue to make machines for us mere mortals that do quite well with what we have.

The machine you are expecting I believe will be the ResMed 9000 Impossible.

[BlackSpinner]

If they cannot do better quality control than this, giving me approximate pressures rather than pretty exact pressures, I say screw them. I am reporting both of them to FDA Medwatch for manufacturing, marketing and selling shoddy equipment. I did not have to do anything like this the first 3.5 years I was on CPAP, its a shame I am having to do this now.

http://www.fda.gov/Safety/MedWatch/default.htm

You are a true idiot. You want to make the machines too expensive for the average person. The machines function within the tolerance specified. They are for home use not space exploration. As I pointed out it is brain dead simple to adjust them to your required pressure - you read your data and adjust accordingly, even a caveman can do it, so can a small kid or a senior with mild dementia - everyone except you.

[sleepycarol]

I find it really really funny he wants his account deleted -- yet is still posting!!!

He can't have both and I think this says a lot about him.

[LSAT]

If they cannot do better quality control than this, giving me approximate pressures rather than pretty exact pressures, I say screw them. I am reporting both of them to FDA Medwatch for manufacturing, marketing and selling shoddy equipment. I did not have to do anything like this the first 3.5 years I was on CPAP, its a shame I am having to do this now.

http://www.fda.gov/Safety/MedWatch/default.htm

You are a true idiot.

Black Spinner.....You got it absolutely right

[DreamDiver]

Knowing how these medical companies have good lobbyists and such, the answer (if any) will probably be "noted and logged." I am going to file a written complaint, but I aint expecting much.

Mikey

Mikey,

My M-Series Pro was poorly calculated too. When set for 11.5, it would actually push out 11.2 according to the manometer. They let me test my M-Series all night long at the lab using a lab manometer just pushing air while I used their sleep equipment. Confirming my suspicions, the pressure would slowly drop by about .2cm by the end of the night to 11.0. And that was a straight CPAP. No machine is going to be perfect. Every machine is going to be different.

Frankly, the calibration isn't all that important. My first titration had me at 7cm straight cpap. Dude, I was asphyxiating at 7cm. I cranked that sucker up to 10. Through trial and error, I found my best AHI resolved to a pressure setting of 11.5 for that machine. My next lab titration conveniently had me at guess what?? 11cm on a properly calibrated machine.

Then we have large leaks and vent rates and mask fit and yadda yadda yadda. This is at best an imprecise science. We're riding unicycles on tightropes every night. We're many of us confessedly 'Monkish' on this forum, as you'll see by the detail to which we discuss some things that don't matter to some. But making sure the CPAP machine sits squarely in the center of your nightstand is hardly relevant in the overall scheme of your cpap therapy. It may be that the level of precision you're requesting with regards to pressure is at best, impractical.

When it comes out of the lab, it's no longer chemistry. It's cooking. We're not interested in having exactly 8 ounces of water to seven decimal points in the tank and a pressure of exactly 9.6000 cm. We slosh some water in the humidifier and strap on the mask and flip a switch.

The best we can hope for is to use the feedback a fully-data-capable machine can give us to hone in on the target pressure regime that works for our bodies with that particular machine.

If you persist in believing the S8 you had was more perfect than all other machines, by all means, buy another S8. Or swap with someone else on the forum who has a relatively new, functional S8 that craves the S9. (That avenue may be problematic if you continue offending other forum members. How's that working for you, anyway?) Here's what I'm betting you're going to find: It's not anything like your old S8. You might even hate it because the pressure settings might not be exactly to your old machine's standard. Maudlin yearning for the 'good old days' will not bring them back. Your pet cat dies -- maybe it's time to adopt a new cat, eh?

[ResmedUser]

Good luck with that!

The problem you have been so vocal about is not about quality control, but rather the specifications. Your own information clearly shows that the pressure is within the specified tolerances and this was pointed out to you a number of times.

Do you realize that the watch you use to tell time most likely is specified to have as much as a 3 minute error over a year. This is an even bigger concern because with that in 20 years you may have an error that can be as much as a whole hour!

Getting back to the CPAP machine, if you truly expect to get a machine that yield "exact pressures" then expect the cost to increase by a factor of at least 50 times, and even then the unit will never be exact, but will instead have specified tolerances to be within the +/-0.1 cmH2O that you seem to be expecting. It may also require costly re-calibration every 90 days or so and can not be moved without voiding the calibration.

I for one hope they continue to make machines for us mere mortals that do quite well with what we have.

The machine you are expecting I believe will be the ResMed 9000 Impossible.

I believe for $863 you should get a machine that has tighter than 1 full CM H20 variation in pressure. That is pathetic and shoddy engineering and design. I bet I could form my own company, hire some PhD types and build better machines than Resmed or Respironics builds and I'd be sure they have tight tolerances. Id tighten it down to plus or minus .1. If you set the thing for 11, it would blow either a 10.9 or an 11.1. Or an 11.0. I would not put all the bells and whistles on them either. Just back to basics, good heated humidifier, good algorithm and NO STOCKS it would be a company I would control. A firm, not a stock owned company. And Id sue anybody that got in my way and theyd be living under a bridge after i got done with them.

Mikey

[ResmedUser]

My former roommates, one an Iranian dude working on his PhD in bioinformatics, another a Chinese foreign National working on his PhD in electrical engineering and a third guy, some guy I did not get along with who also got his PhD in bioinformatics...they all said the same thing. You go overseas and you dont see all these fat people like you see in America. You go to Europe...Germany, Austria, Switzerland...you dont see all these fat people.

Two of them were worried about finding work after graduation....

Hmmmm......


Mikey

[roster]

Finis for me. This is the last morsel I will supply the troll. Slurp it up.

[FredFarkel]

Go for it Mikey -- go and do what NO OTHER medical equipment manufacturer has done.

The entire industry is stupid and YOU are the only ONE smart enough to do this.

Go Mikey Go.

Oh, can you point to any, ANY CPAP machine available with the kind of specs you are talking about -- for any cost? You ever stop to think that perhaps you are the stupid one? And that the rest oif the entire friggin' industry knows something of wehat they produce.

Talk about being brain addled -- hmmm, must of blown out a number of brain cells with that 11 PSI machine he used to use.

Take the challenge -- go find ANY machine produced ANYwhere for ANY cost that meets your +/- 1% spec.

[tschultz]

I believe for $863 you should get a machine that has tighter than 1 full CM H20 variation in pressure. That is pathetic and shoddy engineering and design. I bet I could form my own company, hire some PhD types and build better machines than Resmed or Respironics builds and I'd be sure they have tight tolerances. Id tighten it down to plus or minus .1. If you set the thing for 11, it would blow either a 10.9 or an 11.1. Or an 11.0. I would not put all the bells and whistles on them either. Just back to basics, good heated humidifier, good algorithm and NO STOCKS it would be a company I would control. A firm, not a stock owned company. And Id sue anybody that got in my way and theyd be living under a bridge after i got done with them.
Mikey

Let us all know how that company start-up goes. I am quite sure the PhD types you hire will all tell you the same thing, but then you'll likely fire them anyhow for not telling you what you want to hear. Designing and building for large scale manufacture is not as simple and seamless as you may think it is. But then at the costs that will need to be charged you will have a customer base of only 1 so the manufacturing issues may not be as much a concern for you. I am assuming you are looking for only straight CPAP and no data collection because the algorithms needed for proper auto-titration require much more effort and need extensive data from which the the actual algorithms can be derived. For proper calibration of your equipment you should then have pressure measurement instruments that are possible traceable and have a maximum error of no more than 0.1% of reading to ensure the specs you are looking for.

While I agree with you on the end cost to the customer to some degree, when you consider the required testing before being certified for sale as a medical therapy device, the cost may not be as out of whack as you think. There is also the traditional profit models, with perhaps one or more levels of distribution in the middle.

If you don't like your machine then there is a simple solution, just get something you are happier with, but please this time carefully read the specifications before hand so the same thing doesn't happen again. You are looking for a machine that specifies the total pressure error as +/-0.9% of reading.

[ResmedUser]

Go for it Mikey -- go and do what NO OTHER medical equipment manufacturer has done.

The entire industry is stupid and YOU are the only ONE smart enough to do this.

Go Mikey Go.

Oh, can you point to any, ANY CPAP machine available with the kind of specs you are talking about -- for any cost? You ever stop to think that perhaps you are the stupid one? And that the rest oif the entire friggin' industry knows something of wehat they produce.

Talk about being brain addled -- hmmm, must of blown out a number of brain cells with that 11 PSI machine he used to use.

Take the challenge -- go find ANY machine produced ANYwhere for ANY cost that meets your +/- 1% spec.

You sound scared.

Mikey