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

[eok361]

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Hello. Is it safe now to use Philips Respironics DreamStation Expert Auto Canadian version.

at this point, i wouldn't trust anything philips claims regarding their products. 

i would hope that it's ok, but you should really look into what they have done to correct the problem.

[WakeUpTime]

Is it safe now to use Philips Respironics DreamStation Expert Auto Canadian version. I found one for sale at half price. The seller says that the old one was replaced with this one. It has not been started or activated. The label in the device îs 21.03.2023.

This is only my personal opinion:

1) I wouldn't buy one unless the seller is extremely reputable, and I knew for absolute certainty that it contained the newer foam.

2) I don't like how the DS1's foam placement allows the foam to be in such significant contact with airflow, especially given Philips' foam reputation.  Other brands use the foam more as merely a sound cushion and significantly less foam is in contact with airflow.

3) The updated DS1 foam is significantly better but not great.  If you plan to keep your system a long time, I wouldn't trust it to not deteriorate at all as time goes by.  I also don't believe the Philips updated foam is as healthy as Philips states.  Remember that Philips still insists that their old systems with significantly deteriorating foam containing carcinogenic chemicals isn't harmful to one's health, and their executives went to great measures to hide all reports and data that suggested otherwise.

4) Many CPAP owners received free DS1 replacements after an extremely long 2+ year wait, and they had since purchased another brand of CPAP.  They had no use for their Philips replacement, except possibly as an emergency backup - but even then, many still refuse to use a Philips CPAP ever again regardless of its free nature.  

5) Philips shipped many replacement DreamStaion CPAPs directly to Philips dealers, especially for those located outside the U.S.  A significant percentage of those dealers either couldn't establish contact with the original defective CPAP owners after 1-2+ years, or those contacts rejected the Philips replacement device for various reasons.  Those Philips resellers are working off a 100% profit margin if they then sell the product on the open market.  The fact that they're selling it for "50% off" is a good indication that they probably got the unit at little or no cost.  If you still really want it, give them an offer well below their "sale price".  Even if it's a new or refurbished DS1, I'd still open the system up to examine the air chamber foam for myself.


If your choice is an old Philips system (with old foam) or the new updated DS1 (with the newly updated foam), of course the updated version is healthier.  If your choice is nothing or something, always take something for management of sleep apnea.  If your choice is pay a little more for another brand, or Philips, I'd seriously consider the other brand, if it's widely known and trusted.

Please don't value the seller's advice with such significance.  There are a lot of sellers right now who came across free, or near-free, DreamStation 1s with updated replacement foam.  

(Personal opinion only.)

[eok361]

i'm sure those resellers are making nothing but profit for any machines they sell. 

i wouldn't buy one, regardless. 

i live ina a big enough market that i found 2 resmed machines from those types of sellers at a very reasonable price. one with zero hours, and one with a few hours on it. 

but i get that not everybody has that option.

[TimaaaaaaaahRocks]

This is only my personal opinion:
...
2) I don't like how the DS1's foam placement allows the foam to be in such significant contact with airflow, especially given Philips' foam reputation.  Other brands use the foam more as merely a sound cushion and significantly less foam is in contact with airflow.
...
(Personal opinion only.)

Well you need to use a lot of foam to keep the noise down when you use cheap a$$ motors.  You'd think they'd understand that anything in the air circuit is subject to a biocompatibility analysis, and hey FDA, its not 510k "substantially equivalent" when you change the materials used. 

[btreger]

Philips Recall - Timeline Of The Biggest Medical Device Recall In History

Created By Nicko Dundai

On YouTube

Philips Recall - Timeline Of The Biggest Medical Device Recall In History - YouTube

Warning: Viewer Discretion Is Advised - Contains Swearing, Satire & Australians

[TimaaaaaaaahRocks]

( after 5 years plus these geniuses officially deemed the failures unacceptable, yet they kept shipping them, and ultimately tried to keep the recall on the DL. Let me sum that up, “UNACCEPTABLE!!!” )

About a dozen company officials began to take part in two “health hazard” evaluations in late 2020, including Gary Lotz, the head of global clinical and scientific affairs, Andy Zeltwanger, director of regulatory affairs, Erin Levering, medical safety manager, Neal Pry, manager of quality engineering, Doug Roberts, design quality engineer in safety risk management, and Dr. John Cronin, the medical leader for sleep and respiratory care, company records show. Rodney Mell, head of quality for the sleep and respiratory unit, approved at least one of the studies.


None responded to requests for comment.

The evaluations showed that the deteriorating foam and the chemicals released by the material could cause “serious injury, life-threatening or permanent impairment.”

Both summed up the risk with a single word in capital letters: “UNACCEPTABLE.”

https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared

Maybe Sen. Richard Blumenthal can bully fda into doing their damn jobs. 

[btreger]

AboutLawsuits

Philips CPAP Machine Settlement for Class Action Claims Gain Preliminary Approval, As Personal Injury Lawsuit Negotiations Continue
Philips' CEO has indicated a desire to reach a CPAP machine personal injury lawsuit settlement sometime next year, at a cost many expect will far exceed the $479 million paid in a class action settlement recently announced.

Philips CPAP Class Action Settlement Preliminary Approval

In September, Philips announced it would pay at least $445 million in a CPAP recall settlement to individuals who bought, rented, or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines.

Individual Philips CPAP Personal Injury Lawsuits Remain Unresolved

While the parties appear on track to resolve the class action portion of the litigation, tens of thousands of individuals still have pending lawsuits indicating they suffered actual physical injuries due to their use of the recalled Philips CPAP devices.

Philips CPAP Machine Settlement for Class Action Claims Gain Preliminary Approval, As Personal Injury Lawsuit Negotiations Continue - AboutLawsuits.com

[cate1898]

Hoping someone knows....just finally received a replacement DreamStation GO from my Canadian DME and just checked the recall registration list and the machine I received is on it and it prompted me to register that device for recall. How does one know if Philips has already received this machine and has fixed the recall problem??

[btreger]

Hoping someone knows....just finally received a replacement DreamStation GO from my Canadian DME 

There is no replacement DS GO Machine. I would call your DME and tell them you want to return it and they need to pay for it.
If you had registered your original GO Machine, and have sent that device to this DME, it could mean they are trying to collect the money Philips is offering for its return, up to $500. If you have your original registration number, log on to the Philips Portal and check the status using that number.

[cate1898]

I am not quite sure what you mean when you said "There is no replacement DS Go machine....".  The replacement machines I assume are the DS Go machines Philips has received back from the recall program and have fixed the foam problem (ie; refurbished), and then send out to another consumer, who then in turn returns their faulty recall machine and on and on goes the cycle.  

I am in Canada.  There is no "Patient Portal" for us to check on the status of our claim.  Calling Philips is just an exercise in frustration as the only thing they've told me in the times I have contacted them was that "Canadian recalls are being dealt with separately through Health Canada", and each time I called I asked to speak to their Supervisor.  These Supervisors that I was escalated to were not able to provide any helpful or further info.

I only managed to get my DME to send me out a 'replacement' device as I have emailed, phoned, and had online chats with this online retailer numerous times.  I was a little more direct in my inquiry this time even mentioning in it that there have been deaths due to use of the affected machines and when the heck was I getting mine?  I think it was me mentioning the deaths that finally got their attention and spurred them into action.

To add insult to injury, in June 2016, I purchased a System One 560 Auto CPAP from CPAP.com in the US and had it shipped to a US address whilst I was in the US.  I have heard nothing to date regarding a 'replacement' machine for this one.  US purchase while in the US to a Canadian citizen.  Hmmmm.  I'm guessing I'm completely SOL with regards to this US purchased one.

I can only assume I was shipped out a 'refurbished or remediated' machine that is free from the foam problems outlined in the recall, however, why is there nothing in the literature they sent, nor anything akin to a sticker on the 'remediated' device to indicate it has indeed had the problem fixed??  Also why when I check on Philips recall site and I input the replacement device's SN, why is there nothing there to indicate yes this was a recalled machine, BUT it has been remediated??

I am about to send back my seldom used mint condition (other than the recall problem) DS Go machine to accept a DS Go replacement unit that perhaps was heavily used with no assurance or record that anything was done to recify the problem?