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How important is it to have the latest firmware version?
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JumpStart Offline

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Post: #61
RE: How important is it to have the latest firmware version?
Who knows? Maybe ResMed reads posts on this forum. Anyway, I tonight received the following response to my multiple requests, as posted above:

Thank you for contacting Technical Support. Unfortunately we do not update firmware versions. Our firmware updates are Non-Critical and are considered simple maintenance updates. The only way to get the newer firmware is to get a newer machine. This also means that unless there is something wrong with the machine, we are not likely to replace the machine. I assure you that if your machine is functioning correctly, there is no need to update your firmware. If you have further questions or issues please feel free to contact our technical service department at... (signature)

Whether all of this is true or not, I don't know. Note that they did NOT respond to my query as to what any update contained. I do know that, at some point, ResMed enabled, via firmware, their machines to accept SDHC cards, rather than the older SD cards, which I would not call a "maintenance" update - unless maintenance means improving and/or modifying an existing program. However, on reflection, it may be that any update which is NOT a "maintenance" update requires prior FDA approval, which would undoubtedly be expensive. I should also note that I did NOT direct my query to tech support - that is just how they responded.

Breathing keeps you alive. And PAP helps keep you breathing!
05-11-2012 09:27 PM
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SuperSleeper Offline

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Post: #62
RE: How important is it to have the latest firmware version?
(05-11-2012 09:27 PM)JumpStart Wrote:  Who knows? Maybe ResMed reads posts on this forum.

Gil Ben-Dov (Vice President at ResMed, in charge of Social Media) was a member of Apnea Board back when we were on the old Zetaboards forum software.

Not sure if he still lurks out there...

Unsure

SuperSleeper
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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. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

05-11-2012 10:02 PM
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pssnn Offline
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Post: #63
RE: How important is it to have the latest firmware version?
(05-11-2012 09:27 PM)JumpStart Wrote:  However, on reflection, it may be that any update which is NOT a "maintenance" update requires prior FDA approval, which would undoubtedly be expensive. I should also note that I did NOT direct my query to tech support - that is just how they responded.


Actually "ANY" update would require a "software validation" or validation addendum to an existing validation, depending on the changes to the software and the related risk to the end user (patient). The FDA does not give explicit approval for software changes and leaves that to the regulated company (ResMed in this case). That is all covered by regulations in 21 CFR 820 which regulates medical devices.
There is no requirement in the law (21 CFR 820) that requires the medical device company to disclose information to end users (all of us) what changes to the devices have been made. They are required to keep a file and answer to "customer complaints" by law (21 CFR 820.198) which states in part:

"Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:
(1) All complaints are processed in a uniform and timely manner;
(2) Oral complaints are documented upon receipt; and
(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting.
(b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

I think one can see that complaints is something that a company would like to minimize!

"Goodnight Chesty wherever you are!"
(This post was last modified: 05-11-2012 11:55 PM by pssnn.)
05-11-2012 11:53 PM
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JumpStart Offline

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Post: #64
RE: How important is it to have the latest firmware version?
(05-11-2012 11:53 PM)pssnn Wrote:  Actually "ANY" update would require a "software validation" or validation addendum to an existing validation, depending on the changes to the software and the related risk to the end user (patient).

Good info, pssnn. What constitutes a "software validation" or "validation addendum"? And what part does the FDA play in either? Or is everything on the company creating it?

Breathing keeps you alive. And PAP helps keep you breathing!
05-12-2012 10:31 AM
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pssnn Offline
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Post: #65
RE: How important is it to have the latest firmware version?
(05-12-2012 10:31 AM)JumpStart Wrote:  
(05-11-2012 11:53 PM)pssnn Wrote:  Actually "ANY" update would require a "software validation" or validation addendum to an existing validation, depending on the changes to the software and the related risk to the end user (patient).

Good info, pssnn. What constitutes a "software validation" or "validation addendum"? And what part does the FDA play in either? Or is everything on the company creating it?

The FDA requires that Medical Device (and drug) manufacturers maintain patient safety and product effectiveness. The FDA does not get directly involved with the implementation of policies to assure this is accomplished by the manufacturer. They do however inspect the manufacturers and review just about anything related to the device. If they find that the manufacturer is not complying with the law (21 CFR 820) then they have the authority to force a recall of the devices in question, shut down the company and lock down the facility, seize property or simply issue a "483 Warning Letter". Pretty serious stuff and the FDA can actually show up armed and in military camouflaged uniforms.

The manufacturer is required to show that the software is free from defects and functions as intended before the device is given FDA approval to be placed on the market. This is done by validating the software (as well as the device itself). Once the validation (extensive testing) is complete the software should not be changed unless any changes have been tested to show that it continues to function properly and any changes to the code did not affect the previously validated functionally (regression testing). Sometimes a small change to the code would only require limited testing if the system is already in the "validated state". In that case an addendum to the original validation may be done.

"Goodnight Chesty wherever you are!"
05-12-2012 12:25 PM
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archangle Online
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Post: #66
RE: How important is it to have the latest firmware version?
(05-11-2012 06:05 AM)EyesWideOpen Wrote:  My AHI was reduced to .4 from a 3.5 the night before with my old RemStar Auto. It was really quiet and easy to breathe with.

Different machines tend to give different AHI numbers, so don't put much faith in that.

However, sounds like it's working well for you.

Get the free SleepyHead software here.
Useful links.
Click here for information on the main alternative to CPAP.
If it's midnight and a DME tells you it's dark outside, go and check it yourself.
05-16-2012 03:59 AM
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DCwom Offline

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Post: #67
RE: How important is it to have the latest firmware version?
(05-11-2012 09:27 PM)JumpStart Wrote:  ResMed enabled, via firmware, their machines to accept SDHC cards, rather than the older SD cards, which I would not call a "maintenance" update - unless maintenance means improving and/or modifying an existing program.

This IS a maintenance update internally for Resmed, but not for your machine. Device manufactures don't like to maintain multiple load lines (software versions), so when they need to support something new for the current shipping product (like the SDHC card) they will do a revision to the software for the latest stuff that is shipping. This isn't unique to medical devices or even software, if say Ford is making mustangs and mid model year they want to use a different/better bolt, bracket, etc, then they "upgrade" the part. Unless there is a recall you won't receive the "upgrade" for a previously shipped product.

As for the FDA and part 21 Pssnn did a good job explaining the validation process, which as you can imagine is where some of the high cost of medical devices comes from, there is a lot of overhead to keep this stuff in line.
(This post was last modified: 05-16-2012 07:21 AM by DCwom.)
05-16-2012 07:19 AM
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BabyDoc Offline

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Post: #68
RE: How important is it to have the latest firmware version?
This is my first post on the forum, although I have been lurking around for over a week gathing up information from all of you.
This has been most helpful. First of all, soon after newly being diagnosed with OSA and receiving my RemStar System One Plus C-flex, I learned here about all the advantages of having a data capable machine with APAP, neither of which is a feature of the machine I was given.
I called my sleep physician and was able to get her to prescribe the S9 Autoset in exchange for the machine I was originally prescribed.
The difference between the 2 machines is unbelievable. I already feel better with the Autoset, particularly because they were never able to titrate my exact CPAP needs in the sleep lab (I slept only 2 hours).

The reason I am posting here was because I learned from this thread to look at the run time and firmware version. What I found was the DME had given me a used S9 with nearly 100 hours on it. It also had the 9.03 firmware on it. I called them about a day after getting the machine and innocently asked them if they were aware they had given me a used S9. They appologized for their error and exchanged it for a NEW S9 with the 9.05 firmware on it (I didn't even ask for this firmware version) . Whether all of this makes any difference or not, I don't know. I don't see any difference in the menu options on either the patient or clinical menus between the 9.03 and the 9.05 machines. Still, it is nice to know that for at least the short run, I have the latest and new S9, thanks to all of you.
05-17-2012 09:39 AM
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SuperSleeper Offline

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Post: #69
RE: How important is it to have the latest firmware version?
(05-17-2012 09:39 AM)BabyDoc Wrote:  I called them about a day after getting the machine and innocently asked them if they were aware they had given me a used S9. They appologized for their error and exchanged it for a NEW S9 with the 9.05 firmware on it (I didn't even ask for this firmware version) .

I hear of a LOT of DME suppliers doing this exact same thing. They'll have a CPAP turned back in from a non-compliant user, then try to shove off the used machine as "brand new" to another patient. Usually the other patient has no clue they were given a used machine, so the DME profits by selling used equipment as new.

The reason they're so quick to correct the "mistake" is because it wasn't a mistake - they were trying to make more money off the insurance company or Medicare by getting reimbursed for a brand new machine, when it was, in fact, used.

It's called insurance fraud. That's why they were so quick to "correct" the "mistake"... they don't want you to turn them in for for fraud.

I've heard of way too many of these "mistakes" to believe the DMEs who perpetrate these slick moves are simply making an "honest mistake"... Yeah, sure they did. Annoyed-and-disappointed

Anyway, welcome to Apnea Board, BabyDoc - glad you stood up for yourself and brought this to their attention.

Well-done

SuperSleeper
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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. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

05-17-2012 01:46 PM
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TorontoCPAPguy Offline

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Post: #70
RE: How important is it to have the latest firmware version?
ResMed is not known for playing on a level playing field, that is fact. They ARE known, however, for making a decent APAP machine and accessories for the bux.

Now is their time to step up to the plate and tell all of their users how to update the firmware to 905 or 906 or whatever and WHAT the updates are.

Inquiring minds want to know. I believe it is a fiduciary responsibility on their behalf to take care of this matter.

----------------------------------------------------------------------------
Educate, Advocate, Contemplate.
Herein lies personal opinion, no professional advice, which ALL are well advised to seek.
06-04-2012 02:13 PM
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