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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
PHILIPS RETURNS
(09-09-2021, 10:16 AM)fredHa Wrote:  the note in the box suggested return of ds1 for disposal.  i plan on holding my ds1.  

The Philips fix/replacement process is turning out to be "interesting" to say the least.

Could you please elaborate on why you mentioned that Philips will dispose of the DS1 returns?
(I don't think Philips would know in advance of your return that you opened your DS1 and removed the foam.)

It would be extremely interesting if Philips doesn't intend to fix DS1s and just dispose of them.  If they did, it would seem that they're handling them like tech companies often handle device upgrades - request their returns merely to dispose of them.  I would have thought Philips would fix the returned DS1 and use them as their float for fixing/replacing those with older systems.

If Philips was indeed planning on disposing DS1 units, that would be a major news story indeed.  That would suggest that the DS1's design is so deeply flawed, when it comes to foam placement (in addition to the foam type), that they just want to take them completely out of the field.  Maybe a previous poster was correct in stating that Philips hasn't disclosed their strategy because they don't quite know their strategy and want to keep it a work-in-progress strategy.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
July 2017 - My DreamStation 1 was placed into service.
June 17, 2021 - Registered for the recall.
September 9, 2021 - FedEx just delivered a DreamStation 2 from Philips Respironics. 
"The enclosed DreamStation 2 machine is provided to you as a replacement for your existing DreamStation machine. To insure proper disposal of your current machine, please return the affected machine following the instructions below."
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PHILIPS PLANNED DISPOSALS OF DREAMSTATION 1 DEVICES
Disposal indeed.

The news media and legal firms need to quickly become aware of this new Philips strategic decision.  In my opinion, this is a major news announcement that speaks to the very nature of the DreamStation 1 core design flaws, specifically related to the placement of the foam (with airflow flowing through the foam) and the foam material itself.  

Philips may have reasoned that, even with replacement foam for the DS1, users (especially SoClean or other internal cleaning systems) will continue to experience some form of foam degradation due to the airflow of the DS1 - even with updated non-carcinogenic foam.

But if that is the case, what is the purpose of the mass production of foam replacement kits?  Maybe they're still replacing the foam on brand new DS1s (from DME inventories) or almost new DS1s that are still under warranty.  Perhaps it's only older out-of-warranty DS1 devices that are being disposed of by Philips.  If I'm not mistaken, early DS1 production devices had another type of flaw which was later updated during production (something to do with blower unit seals or something else).

This is a major news update in regards to the Philips Recall.  Many thanks to posters who are continually updating us on their Philips responses.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: >POST 1351

That post I created on 9/1 when 4 separate news agencies had written stories on how the FDA had cleared Philips to proceed with the repair and replacement of affected machines.

The Chief Security Officer, (CSO) I spoke with had no knowledge of the articles, so I e-mailed him the links to those stories.

Today I sent a new e-mail:

"I would appreciate some straight answers on this. The FDA has told the world that it was in control of the recall, and would let everyone know when Philips submitted a proposal it could verify and trust before it authorized Philips to do anything.

I know of a number of people that have been notified by Philips that their new CPAP machines were being shipped. Today I heard from one individual that has received a new Dream Station 2 this morning.

So please tell me what is going on, because the FDA has said nothing.........."

I also sent the same e-mail to The Public Health Program Manager for the AASM.

In the meantime, I can only wait and see if I get any responses.
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RE: PHILIPS RETURNS
(09-09-2021, 12:35 PM)WakeUpTime Wrote: Could you please elaborate on why you mentioned that Philips will dispose of the DS1 returns?

"disposal" is philips own word.  if they had said we need your unit back so it can enter the rework process so it can be redeployed to a person in need in the next months  i would have turned it loose within hours and will if i come to learn that.

to me they devalued the ds1 to the point it was likely to become their trash- in that case i will hold on to the defoamed ds1 and use it with the ds2 as my spare

i appreciate what this device and its predecessor (remstar) have done for me to extend my life- i still remember trying to get my breath at night 15 years ago- it is not trash to me it is a treasure.  the ds2 can do the job but i am not ready yet.
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THEORY AS TO WHY PHILIPS WANTS EARLY DS1 DEVICES DESTROYED RATHER THAN FIXED
It's my (unproven) theory that Philips has targeted as first priority those DreamStation One owners who have owned their systems the longest.  This would make sense because of the DS1's foam airflow issues and the age of the devices.  

It's in Philips' best interest to dispose of (and not update) well-used (older) DreamStation One units IMMEDIATELY.  

Those units contain more significant foam degradation than newer DS1 devices (< 2years).  Philips wants those units urgently disposed of as they most likely have achieved the most foam degradation; evidence that Philips would like eliminated.  The foam in those devices would be substantial evidence as to an individual's inhalation/ingestion - and cumulatively would significantly impact the current awareness of possible harms that may have (or may have in the future) come to device users.  

Class action lawyers, and perhaps even the FDA, should demand that those units be held as real evidence as to device users past ingestion/inhalation of the Philips carcinogenic foam - rather than allow Philips to now immediately destroy those devices.  

The group of older DS1 device owners deserves the strongest levels of "right to know".  If those owners return their devices to Philips for immediate destruction, they will forever never know their current or future health impact.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I don't know if this has been already posted........
https://www.philips.com/a-w/about/news/a...ation.html

And from this link...........
https://www.respshop.com/philips-cpap-re...a-811.html
"On 9/1/2021, Philips announced their new sound abatement foam has been approved by FDA. Philips is now moving forward to manufacturing the new foams and prepare for the actual replacement/repair process. We were told they will kick off in a few weeks (hope it is sooner)."

"On 8/26/2021, Philips confirmed they started replacements for some high risk patients using DreamStation 2 CPAPs (which are using a different foam design and thus not impacted by recall). Philips uses some patient data like whether used ozone, or whether patients are pilots. The data could come from patient registration, Philips remote assistance website Careorchastrator, or other channels. Good move Philips!"

"On 8/23/2021, Philips predicts it takes approximately 12 months to complete the recall worldwide. Although the repairs/replacements are on hold until FDA approves their new foam design, Philips are making 55,000 repair kit per week in Q3 2021, and aim to 80,000 per week in Q4 2021. Once FDA gives the green light, Philips can start repair/replacement asap."

I'm hoping my machine is one of the ones that gets repaired. Not particularly keen on the DS2
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-09-2021, 02:37 PM)StratCat48 Wrote:
Philips confirmed they started replacements for some high risk patients using DreamStation 2 CPAPs
(which are using a different foam design and thus not impacted by recall).

Philips uses some patient data like whether used ozone, or whether patients are pilots.
The data could come from patient registration, Philips remote assistance website Careorchastrator, or other channels. 

For those that are imminently receiving a Philips DS2 shortly by FedEx, Philips is saying that you're in that category.

That certainly explains who will get first priority of shipments, but it does not explain why their returned DS1 devices will be immediately destroyed, and not updated for its replacement float of refurbished DS1 (repaired) devices.  

SoClean-used devices are all targeted for destruction by Philips rather than replacement.  Perhaps Philips has reasoned that additional damage, on top of the quickened foam degradation, may occur to the internal device components.  The procedure of merely asking users on registration would therefore appear to be deeply flawed as some users may not know of the complete history of their device with regards to the use of SoClean:
  • users that have their system periodically cleaned by their DME
  • users that purchased used refurbished systems from 3rd party suppliers
  • users who obtained their new/used/refurbished systems through other channels
So Philips will simply replace the foam on those units and recirculate them back to existing owners or into the general float, when they may have indeed been previously cleaned with SoClean an unknown number of times.  Merely asking the user at recall registration was not designed for integrity.  There was no option under SoClean Use for "do not know".  

This is therefore a warning to users who may possibly receive a future refurbished DS1 device with the replacement foam from Philips' refurbished inventory float, rather than a repair to their existing DS1 device.  They won't be able to know with certainty if their Philips DS1 replacement, if it's from Philips' inventory float of refurbished machines, was previously cleaned with SoClean.  

As a side-note, I know of one user who was afraid to indicate during recall registration that they were indeed a SoClean user, for fear that Philips would not repair their device "under warranty".  Of course, there is no option for them to reverse that indication to Philips.  They'll still eventually get new foam for their SoClean-used device.  It's not a perfect system.

Quote:Philips Care Orchestrator

Philips Care Orchestrator allows home care providers and physicians to manage patient information.  The software provides a central data management system that tracks patient progress, collects and analyzes compliance and therapy data, and provides valuable reports about the data. 

The system is accessed through a supported Web browser, thereby enabling anytime, anywhere access to patient data.  Automatic scoring or diagnosing of a patient's therapy data is not performed by this software.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
after receiving my ds2 this morning - the issue of ozone use being a factor for early ds2 shipments has been questioned.

my registration has fact that i had not used ozone to clean the ds1.  on removal of my ds1 foam, i found it to be in perfect condition - only a thin deposit of white household dust on the end of the foam that faced the incoming air was found. 

discussion also mentioned retention of foam for evidence- mine is in plastic bag which i am keeping.
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PHILIPS DMEs
Previously, the reports were that DMEs could do nothing to assist recalled device users.  More recently, it's becoming more evident that DMEs can indeed do something to put some of their clients on the top priority list with Philips.  One's DME, through the use of the Philips Care Orchestrator online system, can indicate that their client is a high priority replacement device patient, because of their occupation (pilot) or their specific apnea situation.

It seems unlikely that DMEs will actually know, or record in their computer systems, which of their clients are pilots, train conductors, truck drivers, etc.  They may be now urgently updating Philips on that data.  It's also unlikely that Philips would challenge any occupational details provided by a DME.

That's a big reality update with DMEs from "there's nothing we can do".

The question remains, why should this "high-priority" group, that Philips is now urgently providing immediate replacement DS2 devices for, have their recalled DS1 devices tagged for immediate destruction.  One might guess that it's just because Philips isn't setup yet to do their foam fixes and Philips has no intention of carrying an inventory float of refurbished used DS1 devices.  Besides, it's a given that they'd have to use a strong sterilization method if they refurbished devices for other users - and that's what got them into trouble to begin with.

So there it is.  The "high-priority" group will likely get replacement DS2 devices in the next few weeks/months, with their old DS1 being destroyed by Philips.  The non-priority group may get a DS2 replacement, or more likely, will need to first return their DS1 (or earlier) device to Philips and wait a few weeks for the modified version to return.  Not so good for those in the non-priority group.
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