Possible Serious Dreamstation Problems ??

I saw this on another message board...Just passing it on...
https://www.youtube.com/watch?v=NAXkLJ_v9F0

https://www.hmenews.com/article/philips ... NkkUqXXfXc

well, good on 'em for taking steps!

(the article here-https://www.hmenews.com/article/philips ... XfXc-talks of the damage ozone cleaners have done and how philips is spending money to change their material to prevent that.)

i think it's a pity that they feel they have to do this. but it's bound to get them some goodwill publicity.

If I remember correctly, the FDA ozone cleaners warning is buried here in another thread. I'm going to give it a thread of its own.

I was able to pull this from the Philips earnings report call transcript from last week regarding this. Sounds like it’s these ozone cleaners that are the real culprit:

“…On the regulatory matters, regretfully, we have identified possible risks related to the sound abatement foam used in certain sleep and respiratory care devices currently in use and this is primarily related to the first-generation DreamStation product family. We are in the process of engaging with the relevant regulatory agencies regarding this matter and initiating appropriate actions to mitigate these possible risks. Given the estimated scope of the intended precautionary actions on the installed base, we have taken a provision of EUR250 million. I would like to flag that our latest CPAP platform, the DreamStation 2 is not affected as it is of a different design…”

“…And then question number two is on the DreamStation 1 provision. Can you comment on what will physically happen on the ground. Do all sleep apnea machines have to be returned to Philips for repair and/or inspection. What happens if patients need the sleep apnea machine, will you provide a replacement? And thirdly, if I look at the provision, it's around EUR71 for the 3.5 million machines or if the incidence rate of 0.03%, it's a 1,050 machines at a provision of EUR238,000. So it's a wide range? Which one is it? How are you providing for this. Can you give more color on what the maths is behind this? Thank you…”


Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee

“…And then on your further inquiry on the DreamStation. So indeed our current rate, very low. However, the intended precautionary measures will expand to the entire base of the DreamStation 1 related family whether or not symptoms are there. Right, now that's for -- so that's the cautionary approach that we take. If the discussion with regulators lead us to a different conclusion, then that can change, but at this time, we think that this is the most -- the best course of action.

We have calculated this on the basis of an expected time of intervention in the field per unit times the amount of units and leveraging, as I said before, also our DMEs and others. I want to assure everybody on the call that the device is safe to be continued to use to the best of our knowledge at this time. Of course, this will also be discussed with the regulator, but our own expectation is, is that users can continue to use it and then as we repair the units, they either get a replacement unit or they get their own unit back. That still needs to be determined. So I don't want to be completely precise about that. Michael, does that answer your question?…”

Michael Jungling -- Morgan Stanley -- Analyst
It does and maybe a brief follow-up.

“…You mentioned that people are using Ozon, which is against the FDA regulations, are against your user manual. Why is it your problem then if someone wants to use a cleaning agent that is not even permitted. Why are you taking responsibility for that in those provisions?


Frans van Houten -- Chief Executive Officer, Chairman of the Board of Management and the Executive Committee


Well, patient safety is always our concern and we have -- to be very clear, first comes the patient. We don't want to debate culpability at this time or who has done it because that doesn't help the patient. All right and so if there is something to be said about what is the root cause and why did people choose a certain way of cleaning the device, yeah, then that can be an endless debate. At this time, that should not be the debate.

We should just deal with the issue and then later on, we can sort out whether -- how these cleaning came about. I mean if we look around the world, then the use of Ozon is typically a U.S. issue and then within the U.S., it is related to certain regions where certain companies have been very active in marketing that method, but that's all, let's say 2020 hindsight. The FDA observed this and also put out a safety notice to say don't use Ozon for sleep ap machines, right. Nevertheless, we are -- we cannot control that, right, but we don't want to focus on culpability questions. Our prime concern is, let's take this small risk out of the market and deal with it proactively…”