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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-28-2021, 08:34 AM)btreger Wrote: I can totally agree with that statement. That is why I recommended a third-party lab, as a Medical University Hospital that is fully equipped and staffed with doctors and scientists who could do this particular job.

Lots of testing and studies are done by independent labs and the results compiled and submitted by the manufacturer.

I just don't see it being the panacea you think it would be, even if such facilities could be found and the work completed in a timely fashion.


Here, the best I can tell so far is Philips used a material that had been in use for a long time. They later found an issue with it and are scrambling to correct it. Unfortunately this market is such that there isn't a lot of excess capacity, especially post pandemic where a lot of resources were re-tasked to support that effort (making ventilators instead of PAP machines). And the government agencies slow things down a lot. 

Look at the approved foam for the DS2. It's only for 2 machine types. The FDA approves for each machine type separately.
They won't just say change foam A to B in all the machines, new or old.

Saw it years ago with inhalers. CFCs were banned so they needed a new delivery system. That would approve a blanket switch for all the exiting manufacturers. Each had to do full, separate approval, and for many it wasn't cost effective to do that, so the options decreased and the costs increased.
 

It's the same with auto recalls. They don't have a fix or the parts when a recall is announced. I had one recall affect me where the temporary solution was disconnect a system. Then 6 months later there was a fix, but it took another 8 months to get the parts.

Thankfully it wasn't an important system. But if it had been, the vehicle might have been unusable for 14 months, or I'd have to use it and risk the know problem.
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CERTIFIED (FAULTY) DEVICES CIRCULATED FOR 15 YEARS
Just to chime in on the discussion, except for prescription drugs, most products requiring authorization don't go through long-term testing in real live customer environments; instead opting for simulated use within laboratory conditions, all under the strictly defined structure set up by the product manufacturer and testing facility.  

As we now know, the degree of foam breakdown varies by:
  • pressure settings (low vs higher)
  • device type (CPAPs vs BiPAPs and ASVs)
  • internal cleaning
  • device age
  • device family (DreamStation, System One, etc.)
  • room humidity
  • room temperature
  • perhaps even use of a device humidifier with varying heat temperatures
  • perhaps air pressure and varying elevations
  • etc.

How can Philips' lab request possibly simulated all the above permutations and combinations?  As a result, a minimalist testing philosophy endures.

The very short-term laboratory simulated data is then projected over long-term periods to demonstrate long-term safety.  The results are then forwarded to the product authorizing agency.  Allowing industries to 'self-monitor' themselves and merely update government agencies on their findings can produce poor results longer-term.

This is one of the contributing factors in how 4 million faulty devices were allow to continue to be certified for 15 years.  Upon early reports of foam breakdown by customers, Philips could have immediately examined its various PAP systems in a random group of 50-100 customers in various environments.  They could have offered complimentary device upgrades in exchange for that research data.  I imagine that there would have been some very frightening results with some devices.
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RE: CERTIFIED (FAULTY) DEVICES CIRCULATED FOR 15 YEARS
(09-28-2021, 11:14 AM)WakeUpTime Wrote: This is one of the contributing factors in how 4 million faulty devices were allow to continue to be certified for 15 years.

Of course they designed them with what, a 5yr life (and new devices enforcing that).

When I bought my System One 60, 5 1/2 years ago, it was old stock of a discontinued model.

That's why I really don't expect much from Philips for it. And I don't want a DS2 any more than I wanted a DS1 back then.
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PAP DEVICE LIFE
If I'm not mistaken, the 5-year device upgrade schedule is a recommendation rather than a safety requirement.  If it was an absolute, Philips (and other manufactures) should be putting expiration dates on all PAP devices just as the manufacturers of children's car seats now provide.  Better yet, they could hardcode an expiration date into their PAP devices.

For a variety of reasons, all PAP manufacturers don't (yet) do that.  Instead, they stick to the word "recommended".  Legally speaking, Philips must therefore fix/replace devices going back to 2007.
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RE: PAP DEVICE LIFE
(09-28-2021, 11:41 AM)WakeUpTime Wrote: Better yet, they could hardcode an expiration date into their PAP devices.

For a variety of reasons, all PAP manufacturers don't (yet) do that. 

They seem headed that way.

It not about a safety limit, just the expected life span/support period.

Is Philips even making parts for the System One any more. Or is it just old stock and 3rd party parts.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Oscar Developers

Is this true, it was posted on the Facebook CPAP Reviews? 

Philips is now encrypting the sleep data in the #cpap_dreamstation2 so that patients can no longer use #cpap_oscar to understand their sleep data.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
It is true. Philips, in all their wisdom, elected to encrypt the DS2's data.
Crimson Nape
Apnea Board Moderator
www.ApneaBoard.com
___________________________________
Useful Links -or- When All Else Fails:
The Guide to Understanding OSCAR
OSCAR Chart Organization
Attaching Images and Files on Apnea Board
Apnea Helpful Tips

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.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-28-2021, 01:06 PM)Crimson Nape Wrote: It is true.  Philips, in all their wisdom, elected to encrypt the DS2's data.

Was the DS2 always encrypted or is this a new development?

I knew I didn't want one but dang.
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RE: PAP DEVICE LIFE
(09-28-2021, 12:10 PM)ST Dog Wrote: Is Philips even making parts for the System One any more. Or is it just old stock and 3rd party parts.

As someone recently posted, strangely Philips submitted documentation for FDA approval in the fall of 2020 for an A-Series Humidifier.  We're trying to figure that one out.  Philips either has a significant inventory of replacement parts and/or is continuing to produce components.  For example, replacement humidifier water reservoirs seem to be a supply often needed for replacement of leaking tanks on the Series 50s and 60s.

During the recall service ("fix") process of older Philips Systems (dating back to 2007), there are bound to be components that break during the service "fix".  I imagine if that happens during the repair done by some 3rd party contracted technician, they may elect to just replace the machine.  

So far, the Recall has been easy for Philips - merely providing DS1 CPAP and APAP users (who have updated settings in the Philips Cloud) with a DS2 replacement device.  Soon, it's going to get complicated.

Regarding significant discussions on the DS2, perhaps we all should consider starting or contributing to existing DS2 threads outside of the Recall thread.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
ST Dog - The DS2's data has always been encrypted. That is the main reason OSCAR doesn't currently support this model.
Crimson Nape
Apnea Board Moderator
www.ApneaBoard.com
___________________________________
Useful Links -or- When All Else Fails:
The Guide to Understanding OSCAR
OSCAR Chart Organization
Attaching Images and Files on Apnea Board
Apnea Helpful Tips

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.
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