[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[btreger]

I am glad we all took Sunday off, I think we all needed a break.

I would also like to thank the handful of people on this post that seem to have their s.... together. Their input has made me more intent on digging deeper into this, it is my health that motivates me.

Now for a few Quotes:

  This is from the AASM

  FDA questions safety of CPAP cleaning devices using ozone or ultraviolet light

Today the U.S. Food and Drug Administration released a safety communication and consumer update to inform patients and health care providers about concerns related to CPAP cleaning devices that use ozone or ultraviolet light. CPAP is a common treatment for obstructive sleep apnea.
The FDA reported that devices claiming to clean, disinfect or sanitize CPAP devices or accessories (such as masks, tubing, headgear) using ozone gas or UV light are not legally marketed for this use by the FDA in the U.S. According to the FDA, it is unknown if these CPAP cleaners are safe and effective.
To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA recommends that consumers and health care providers follow the cleaning instructions provided by the CPAP manufacturer. These directions normally include regular cleaning with soap and water.

  As a side note to this, If you can't trust Captain Kirk who can you trust.

  This from the NIH

  Steps for cleaning and disinfection of plastic pieces of respiratory equipment:

Sterile water is preferred for rinsing, because tap or distilled water may harbor microorganisms that can cause pneumonia. However, when rinsing with sterile water is not feasible, instead, rinse with tap water or filtered water (i.e. water passed through a 0.2 μ filter), followed by an alcohol rinse and forced-air drying.

  I felt I needed to post this, I am still using distilled water, and having a hard time getting my own head around this information. As another post stated, we all have to make our own decisions.

Burt

[E.W.]

It's sort of funny I got a form letter  from "cpap support company"   informing me " most valuable customer"  that
as my pap was over 5 years old if I wanted a replacement call them at 855 7834535 .  For just a split second  I had
my hopes up that this was about the 2 cpaps I had registered for the recall the day before.  I wonder how I got on 
that junk mail list.  But back to the recall it's my understanding they may repair my Dreamstation  but will replace my
system one bipap is that right. Do we have any idea how long this process will take ?

[khayla91]

hye im from malaysia.. sorry my grammar is too bad. i buy dreamstation go did my cpap machine replacement?

[Sleeprider]

khayla91, the Dreamstation Go series are affected by the advisory and recall. At this point, Philips is only recalling machines in the U.S.A. and has not announced a plan for replacement in other countries. Register your device on the recall website http://www.philips.com/src-updates

[mandarla]

I registered both my DS and DS Go - as both are on the no-no list....then asked what do I do now and was told to contact my pulmonary specialist - seems his contact points are all down - he was pushing DS so hard he had a room full of them...bottom line - looks like we are all left to fend for ourselves - what makes me wonder of all mfgrs. are using the same sound deadening foam....wouldn't be so bad but these machines have been on the market for many years...
Mandarla

[Guilhermedico]

In December 2020, I ordered a non-branded mini ozone generator from Amazon and I started to use it to "clean" my 15-year old Respironics M-Series Auto BiPAP unit and my masks on 1 January 2021. I was concerned about a powerful odor emitted by the ozone unit, much more pungent than with a prior ozone-generator I had used on long trips abroad, but I continued to use the ozone to clean my M-Series machine, hoses and masks. Although I do not think the ozone-generator had anything to do with its demise, my M-Series device died in late February 2021. But what really alarmed me was that the cushions on all of the Resmed Mirage Quattro full-face masks I was using at the time, all of which were brand new as of 1 January 2021, turned a bright yellow color by late February, something that had never happened with a previous non-branded ozone-generator.

In March 2021, I purchased a Philips Respironics DreamStation Auto BiPAP machine, the successor model to my now defunct M-Series unit. I read the warning about the warranty being voided if ozone generators are used. Heeding that warning, and related to my concerns about the change in color of the Mirage Quattro mask cushions, I decided NOT to use the ozone-generator ever again, with either the new PR DreamStation machine or with the new Resmed AirFit F20 full-face masks I purchased at the same time to replace the discolored Mirage Quattro masks.

Now, with the latest information about how these ozone generators are a likely contributing factor to the outgassing of the sound insulation foam on the Philips Respironics DreamStation and other PR machines, I am thankful that I read the little booklet that came with the DreamStation and that I had the common sense to recognize that the yellowing of the mask cushions might be something of concern.

[btreger]

I personally have not seen or read any information on this post or anywhere else that has proven any link to the use of an ozone cleaner and the Philips recall. There might have been some speculation out loud about this, but as far as I know, it was only speculation.

[buddy0329]

After trying and failing last week, I was able to get through to the Philips support line @ (877) 907-7508 today:

• Last week the support line queue would kick-off with a message about expected hold time of ~15 minutes, counting down every 5 minutes or so.  At the end of the 15 minutes, the system would kick me back out to the top menu and start the process all over again.  For my amusement  I kept the phone line open for 70 minutes until PR eventually disconnected the call.
  
• Today the call queue was setup differently. The phone system was now telling me there were ~130 people ahead of me in the queue.  The queue moved fairly quickly hold time + Q&A lasted 30 minutes.
  
• The rep I spoke to today seemed generally uninformed and was relying on a script.  I wouldn't be surprised if Philips outsourced this to a 3rd party call center; I say this because the representative  kept referring to Philips as "they" and "them".
  

The following points by the representative were most interesting but also likely to be of questionable merit :

1. No timeline on next steps.  Philips is awaiting "regulatory approval" for their plans.  I pressed her on if this could be days / weeks / months, but she would not elaborate further.
   
2. Philips would most likely be sending out new replacement units to patients who registered impacted units on their website; this was off the cuff and did not seem to be read of a script.  When I asked for references on the Philips website, the representative could not provide one nor account for Philips' statements of their intent to "Repair" these units per their website.
   
3. Philips will be prioritizing situations where the clinical need is "most acute".  How will they determine how acute each patient's situation is?  I wanted to ask, but knew the representative likely had no idea.
   
4. Philips would be reimbursing $$$ to patients who had to purchase replacement units; this was was very clearly being read off of a reference document and/or screen to me.  This seemed like a pretty big deal.  When I asked for official references on the Philips website I was put back into the call queue.  Take this for what it's worth.
   

I'm an owner of a Dreamstation (4.5 years) and Dreamstation Go (3-years).  I'm ready to replace the DS1 now out of pocket; I could buy an Autoset 10 now, but it seems like the 11's will be available in August. Ugh.

[WakeUpTime]

The fact that Philips has admitted to the connection now (and early on warned against the use of ozone cleaning products) makes it 'moot' at the moment to provide the specific details and laboratory analysis of the deterioration and ingestion of the cancer-causing foam particles used in Philips recalled machines.

If my Toyota or Honda vehicle has an airbag recall, I don't need to investigate the scientific proof, or to challenge the manufacturer's recall of airbags.  If the long-term use of consuming or inhaling RoundUp spray is now known to cause cancer in some/many people, I don't need to read the laboratory details.  If it has been shown that J&J Baby Powder can lead to cervical cancer in women, I don't need to see the research papers.

I understand there are some that greatly wish that this significant recall was never announced, even though the potential harmful affects had become known.  This has created significant issues within the industry which has put significant financial pressure on some businesses.  For example, if I was a smaller DME that almost exclusively sold Philips machines, I might not be content at the moment.


If viewers haven't already done so, please consider adding a comment and your vote at:

PHILIPS SYSTEMS RECALL - Future Purchases [POLL] | Apnea Board

[Guilhermedico]

I personally have not seen or read any information on this post or anywhere else that has proven any link to the use of an ozone cleaner and the Philips recall. There might have been some speculation out loud about this, but as far as I know, it was only speculation.

Although the Philips Respironics recall website did couch the connection with the modifying words "may be", perhaps at the direction of their legal staff, it is nevertheless concerning to see the visual effect of ozone on a soft plastic mask cushion within the space of less than two months, as happened to all of my Resmed Mirage Quattro masks. I, for one, would not dismiss ozone as a potential accelerant to the outgassing of chemicals from the sound-insulating foam, perhaps not the sole cause, but likely a contributing factor.

From the Philips recall news release dated 2021-06-14:

"The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation."

By the way, the double asterisk (**) leads you to an FDA Safety Communication link:

**    Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication dated 2020-02-27. 

That FDA page largely discusses potential risks of elevated ozone levels on people with respiratory conditions, but does not address the question of a potential direct effect on the components of a PAP machine, e.g., the sound-insulating foam.

[Note: I apologize for not posting the live links to the webpages I have referenced above but, as a newbie to this forum, I am not yet permitted to display hyperlinks in my posts.]