Product defect: information from Philips Respironics

[Miss Emerita]

If you use a PR machine, please be aware that the company has announced a product defect. Here is the URL:

https://www.usa.philips.com/healthcare/ ... src-update

And here is what the web page says, copied and pasted:


Sleep and respiratory care update
Questions and answers

On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.

Philips has determined from user reports and testing that there are possible risks to users related to the sound abatement foam used in certain of Philips sleep and respiratory care devices currently in use. The risks include that the foam may degrade under certain circumstances, influenced by factors including use of unapproved cleaning methods, such as ozone*, and certain environmental conditions involving high humidity and temperature. Philips’ recently launched next-generation CPAP platform, DreamStation 2 is not affected.

To date, we have not received reports of serious patient harm related to this issue.

Philips takes this matter very seriously, and is working to address this issue for our customers and patients who rely on our sleep and respiratory care solutions.

* Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
What devices are impacted?
Sleep Products

DreamStation CPAP
DreamStation BiPAP
DreamStation ASV
DreamStation Go CPAP
DreamStation Go APAP
OmniLab Advanced Plus(sleep lab) CPAP
50 Series CPAP
50 Series ASV
60 Series CPAP
60 Series ASV
Dorma 400, Dorma 500, & REMStar SE Auto CPAP (value line)

Respiratory Products

DreamStation AVAPS/ST
C Series AVAPS/ST
A 40/30
Trilogy 100
Trilogy 200
V30 Auto (hospital use)
E30 (hospital use)

What products are not affected?
Products not affected:

Trilogy Evo
Trilogy Evo OBM
EV300
Trilogy 202
A-Series Pro and EFL
M-Series
DreamStation 2
Omnilab (original based on Harmony 2)
Dorma 100, Dorma 200, & REMStar SE
All oxygen concentrators, respiratory drug delivery products, airway clearance products.

Products that are not affected may have different sound dampening foam materials, as new materials and technologies are available over time. Also, sound dampening foam in unaffected devices may be placed in a different location due to device design.

Are affected devices safe for use? Should affected devices be removed from service?

Affected devices may continue to be used in accordance with their instructions for use.
What is the safety hazard associated with this issue?

In accordance with the Philips Quality Management System, the company continues to review potential health risks related to this issue, for reporting as required under governing medical device regulations and laws.

Has Philips received any reports of patient harm due to this issue?

To date, Philips has not received reports of serious patient harm related to this issue.

Philips has received a small number of reports of low severity harms such as headache, cough, and throat irritation. There have been no reports of serious injuries or death associated with this issue.
How many devices are affected? Is this worldwide?

This issue affects devices worldwide.
How will Philips address this issue?

Philips takes this matter very seriously, and is initiating actions to mitigate possible risks to patients.
Are there any steps that customers and/or clinicians should take regarding this issue?

Philips will provide further information to customers and clinicians as part of our ongoing preparations to mitigate this issue.

[chunkyfrog]

As mentioned before, the timing of this recall is very, very suspicious.
Are dealers being reimbursed or credited for units in stock?
If so, patients should be afforded a similar courtesy.
ABSO-FREAKIN'-LUTELY!
See the video by Thelankylefty--he has some choice things to say . . .

[colomom]

As mentioned before, the timing of this recall is very, very suspicious.
Are dealers being reimbursed or credited for units in stock?
If so, patients should be afforded a similar courtesy.
ABSO-FREAKIN'-LUTELY!
See the video by Thelankylefty--he has some choice things to say . . .

The notice posted by Ms. Emerita is concerning, but it is pretty vague (the high paid lawyers from PR likely earned their money).

Could you please provide a link to the video you mention, i have no idea where to find it. Thanks!

[KingSnore]

Well then.

So this means that as long as I haven't been using weird cleaning devices, my 60 series is fine? I certainly haven't noticed ill effects.

edit: Oh, it says high humidity too. Yeah the midwest is pretty humid. good grief

[chunkyfrog]

Link to thelankylefty's video:
https://www.youtube.com/watch?v=yuR2oY5tYyU

[Miss Emerita]

Terrific rant by LL!

[palerider]

It looks like this is nothing more than Philip's way of saying "What Resmed said about all those hack "cleaners".

[chunkyfrog]

It looks like this is nothing more than Philip's way of saying "What Resmed said about all those hack "cleaners".

But capitalizing on it to sell their latest product . . .
Yeah, I saw what they did.

[palerider]

It looks like this is nothing more than Philip's way of saying "What Resmed said about all those hack "cleaners".

But capitalizing on it to sell their latest product . . .
Yeah, I saw what they did.

Fair point, the more I know about Philips Respironics, the less I like them.

[Dog Slobber]

It looks like this is nothing more than Philip's way of saying "What Resmed said about all those hack "cleaners".

But capitalizing on it to sell their latest product . . .
Yeah, I saw what they did.

Fair point, the more I know about Philips Respironics, the less I like them.

Don't want to jump in defending Philips, I don't like how they handled this, but the biggest culprit in this whole deal is SoClean and other ozone devices.

The list of P.R. machines is extensive and goes back a long time. For this to become an issue significant enough to issue press releases, on machines 10 years old, the problem isn't the machine.

Respironics (and ResMed) need to issue stronger statements.

The list of materials not compatible with Ozone is well known. CPAP device manufacturers should be very clear and very firm.
ie

• The foam [ list other ozone compatible] within our devices are incompatible with ozone. Using ozone will cause premature break down. This will void the warranty and likely result in a shortened machine life span.

But, it's getting to the point where I simply don't give a crap anymore. The information is out there. And if the CPAP makers don't want to make firm statements, and they take losses as well, it looks good on them too.

[chunkyfrog]

Next lawsuit against "sc" --who files it?
Better yet: how many zeros?
This is getting fun.

[esel]

And I thought that these machines had filters and that the air we breath in is pure and clean - ?

lucky us, lungs are well equipped with hairs and mucous which bring up these particles we then swallow or spit out.

[palerider]

And I thought that these machines had filters and that the air we breath in is pure and clean - ?

lucky us, lungs are well equipped with hairs and mucous which bring up these particles we then swallow or spit out.

The filters are at the inlet of the machine,

running parts destroying ozone backwards through the outlet... it probably never gets to the filter, (which it might degrade).

[chunkyfrog]

And I thought that these machines had filters and that the air we breath in is pure and clean - ?

lucky us, lungs are well equipped with hairs and mucous which bring up these particles we then swallow or spit out.

Those hairs are at risk if one is a smoker, and possibly a tobacco user by other means.
Kill those hairs, and crap stays in the lungs . . .