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

[buddy0329]

Thank you - never saw a confirmation number flash... perhaps due to using firefox.

I used Firefox.

It was easily missed.  All white background, nothing bolded, and within a few minutes it timed out.  Such a cluster.

[WakeUpTime]

In helping another user with their registration of a Philips recalled device, I noticed the Confirmation screen response has changed from earlier responses that normally just quoted a Confirmation Number.

The latest Philips Recall Device Confirmation page now says, after the Confirmation Number:

PHILIPS RECALL DEVICE CONFIRMATION SCREEN (UPDATED):

We regret that it may take some time to replace your device. The repair process for existing devices requires regulatory approval in your country, which we are working toward obtaining as quickly as possible. We will begin the repair/replacement process immediately upon that approval.

When the repair/replace process commences, we will prioritize the devices that support patients with more advanced clinical needs. We understand the impact of this issue on your therapy and we sincerely apologize for this disruption. It is our absolute number one priority to replace affected devices as quickly as possible.

For additional questions:
For more information and updates, please visit Philips.com/src-update where we will be updating answers to frequently asked questions (FAQ) as more information becomes available.

If you haven't already done so, please consider adding your vote (and post any comment to keep the poll active) at:

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

[btreger]

I have a question for the Apnea Board:

If all the participants of this Thread were to submit the manufacture date of their recalled product, for example, 06-25-2018 would you be able to track that?

The reason for the question is to see if the recalls are linked by date. So if there were no recalls after 07-25-2018, that could tell us that Philips found a problem, material, vendor, process, etc.

This won't change anything but would provide the information we do not have now.

Thanks

Burt

[Guilhermedico]

Thank you - never saw a confirmation number flash... perhaps due to using firefox.

I was using the Chrome browser on a PC and did see the number. I had enough time to write it down quickly, but it would have been respectful to end users if PR had sent registrants an automated email with the confirmation number. FYI, the confirmation number is 16 digits. 

The first 8 digits are the date you registered with the PR recall site in YYYYMMDD format. That is followed by another 8 digits of uncertain significance. Hopefully, the magnitude of those final 8 digits does not indicate the chronological order in which one registered at the recall site. My last 8 digits are not too far below 02000000 (i.e., 2 million)!
 

[btreger]

I think Philips answered some of my questions.
From Philips

---

Sorry, that was a slip.

Philips answers some important questions;

1. Are affected devices continuing to be manufactured and/or shipped?

 At this time, affected devices are on manufacturing and ship hold as the company prepares to implement the repair/replacement program for affected devices, to install new sound abatement foam material not affected by the reported issues.

2. What is the cause of this issue? Was it design? manufacturer, supplier, or other problems?

Based on Philips analysis, the root cause of this issue is related to the sound abatement foam currently used in specifically identified products of the Sleep & Respiratory Care portfolio.

3. How did this happen, and what is Philips doing to ensure it will not happen again?


Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue.

 

The products were designed according to, and in compliance with, appropriate standards upon release.  As new standards are developed, they require the assessment of product characteristics according to quality and regulatory processes.  Philips Quality Management System has been updated to reflect these new requirements.

 

However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. The foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements.

 
Philips has been in full compliance with relevant standards upon product commercialization.

[WakeUpTime]

The Philips device recall, related to the "possibility" of ingesting a cancer-causing agent as a result of the deteriorated sound-reducing foam, has me wondering about these points:

(1) In any system, would operating a device (unmasked) at a maximum pressure for a period of time serve to periodically "clean-out" loose dust or other particles within the device air chamber prior to use?

Doing that on a Philips Recalled system might do more harm than good though by possibly speeding up the deterioration of the foam - for those continuing to use their Recalled Philips devices, contrary to Philips' instructions to immediately halt using the Recalled Philips devices.

(2) Recalled Device users are following Philips' instructions and purchasing replacement systems. How exactly is repairing a Recalled device many weeks/months later (and returning it to the user as a second system) really going to provide satisfaction to users who were suddenly forced to spend an additional perhaps $1,000-$3,000, depending on whether or not they have insurance support.

(3) This Recall gives additional reasons for PAP users to choose PAP systems with removable SD cards. A user's record of historical use is significant evidence of the precise number of hours used on a specific Recalled Philips device. One never knows if that usage data might be relevant one day. It's true though that other systems may send that data to the cloud for later use too - though I prefer to keep it local.

[btreger]

Philips has stated the following on their web page:

"The products were designed according to, and in compliance with, appropriate standards upon release". 

The only documentation I could find so far on standards is this from the ASA:

"CPAP or BIPAP BiLevel positive airway pressure machine should not emit more than 35 DB in noise.

Humidification should be an option.

Machine pressure range should be at least between 4 cm - 20 cm.

The mask interface should be without sharp edges on the face and should be clean according to state and federal requirements.

The mask should have an adjustable strap that attaches the mask to the face.
CPAP and BiPAP machines and masks should be appropriately cleaned with proper CPAP cleaning protocol and/or the use of a CPAP cleaner machine".

This is what I found on the use of foam in medical equipment:

"Acoustic insulation reduces airborne sound, structural resonance, and increases the noise blocking potential of these enclosures, improving patient comfort, and equipment operability. Both POLYDAMP® Acoustic Foams and POLYFORM® Molded Foam can increase acoustic absorption and improve the performance of equipment. Considering a molded foam solution at the inception of a product is the best way to ensure equipment efficiency and operability".  

I have not found any definitive standards, Philips has stated they are in compliance with....... 

[Ockrocket]

I don't know where we stand here in Australia as yet..
Not sure if replacements will be offered or not at this stage.

I got my Dreamstation five years ago, the company I bought it through is no longer in business.. so no path there to follow up on.

Also I gave up using CPAP last September, and have no intention of starting to use one again at this stage.
Covid has put an end to my hire car business, so I've dropped all my professional driver endorsements and basically retired - so I'm no longer required to prove CPAP compliance for my licence (though I still have to pass a fitness to drive assessment by my doctor, I no longer need to have a specialist sign off on me).

But either way I'm thinking I'm up sh1t creek without a paddle on it all, so probably won't pursue a replacement or financial recompense.

Fortunately I haven't used an ozone cleaner, in fact my cleaning regime was almost non existent,  and was only the small intake filter replacements, along with mask and hose cleaning with warm soapy water every two or three months.
I gave up using the humidifier very early on as I was more comfortable and less congested without it, so that has hopefully reduced the likelihood of the foam deteriorating, and the bedroom was temperature controlled by the reverse cycle air-conditioner.. so excessive heat shouldn't have been a contributing factor causing deterioration of the foam either.
My risk level should be minute - but I will pull my machine apart and check for any deterioration of the sound deadening foam just to be certain.

With no longer having to set an alarm clock every morning, and being able to sleep 8 hours or more of totally undisturbed sleep, I'm feeling very rested.

Hopefully those of you who need replacement machines urgently get looked after properly by PR and their retail agents.

[racprops]

Racprops, you have a tendency to draw large, universal and definitive conclusions from scant or dubious information.

I could not have said it better myself.  

None of us are experts on this issue.  It is all about limiting your potential exposure.

I would be concerned if I had an older machine, used ozone or other harsh cleaners on my machine.  I would certainly stop using it, if this were the case.  I have decided since I have a newer machine, that I will clean with warm water and mild soap more frequently.  I have also purchased inline filters as another means of protection.

However, I most certainly do not agree with opening up my device, cutting it up and introducing plastic particles and dust, removing and disturbing the foam, then using glue or duct tape to heal the scab created.  That seems like a pretty foolish idea to me.

I do not claim to be any kind of expert. I do claim the following:

I started repairing cars at 16 in 1965, (I was self educated) and then was trained in A/C and heating repair and got my journeyman card in 1970, worked two summers and no winters (work crews was 30 in summer 10 in winter) then was trained in TV repair and service and repair TVs up until 1978, then I became a TV and Movie Prop maker and I still am.

Again all the skills in model making, mold making, electronics, plastic casting, and hand prop design I learned by my self.

I have been troubleshooting everything around me all my life. I still service my own cars with Fuel injection etc.

The ONLY THING I cannot repair is a automatic transmission, everything else I can and do.

SO I have been fixing and service things for 56 years.

I think my 56 years of servicing and repairing all kinds of stuff should mean I have a good understanding of repairing stuff.

So when facing this problem I watched the videos on utube to get an idea what the problem was. 

Seemed simple: there was this black foam inside a chamber. This black foam was the danger. IF there was no foam no danger.

The foam in contained in a sealed plastic container. So I did the smartest thing I could come up with: Cut a small opening and remove the foam.

I gave this a lot of thought, the major problem in my book was how to seal the container after cutting these cuts once I have removed the foam. 

I figured I could not say if any glues that can hold this plastic as any glue I use  might it them-self's cause health problems. So I did not use any glues.

Now I cannot prove this BUT Duct Tape is called DUCT TAPE as it is used in repairing and closing and sealing heating and A/C DUCTS.

I have never seen any recalls of duct tape as any health risk.

So by default I figured that the VERY small amount of duct tape adhesive that will be exposed to the air of the chamber though the four one inch cuts and the two about 1/2 inch cut of the two openings I made to allow me to LIFT these two flaps to remove the KNOW DANGEROUS foam. Once the foam was removed I then bent the flaps back in place and sealed them with duct tape.

I really think the removal of the LARGE amount of deadly foam vs the VERY small amount of duct tape's glue was a far better trade in risks.

And as there is so very small amount of exposure of the duct tape VS all that foam.

I now can and have slept very well knowing I am not exposed to the black foam while I wait the upcoming weeks to months for Phillips to do what they are going to do.

NOW let me add this fact to my doing this.

I have had to both self treat and self buy my own sleep machines for the past five years.  I still get supplies from my insurance from a local DME, and I have  Sleep Doctor whom kind of endorses my chose of using a ASV machine. IE he will not put that in writing, other than writing me a prescription for a ASV machine stating my insurance will never pay for them but I am welcome to buy my own machines, which I have done.

As my machines are NOT supplied by my DME I am very concerned as to what I will receive and what when if ever. At best by the DMA I might get a plan old APAP machine...

So I have looked into what to do. I was able to buy a used refurbished ResMed Aid Curve 10 ASV machine for $1300.00. That is a major hit to us. A refurbished machine is tested, cleaned by approved cleaning systems by the manufactures standards, the filter, hose, and water tanks are replaced (normally) other wise it is a used machine.

At this point I have used it for two nights. I am NOT impressed. It needs a new fan. The humidifier does not seem to working correctly.

It came with a full return deal for 10 days and a 6 month warranty.  So repairs will not cost me any more for the 6 months.

I also have been given the costs of a full rebuild of this machine at $450.00 to $500.00 which covers a replacement NEW Mother board and a new fan.

I for one do not love the ResMed unit. Comparing it VS my now safe to use Phillips to the ResMed I prefer the Phillips.

I am writing my review of the Resmed machine at this time.

I am considering if I will keep it and send it back for the repairs, or return it for a refund, or even really take a deep hit and buy a new one for $2200.00 (IF I still can...)

OR just use my repaired Phillips machine until there is action from Phillips.

Which I think will be a mix of three actions: replacement with the New DS II for those that have a say 3 to 5 year or newer machines.

Replacement of the housings with either no foam or so called safe foam, I pray we will be able to chose...

And lastly denial of any action for older machines or of self bought out side the normal supply lines, as in used etc and not handled by any DMEs.

IE ME!!

Rich

[attachment=33120]

[attachment=33115]

[attachment=33116]

[Rich66]

Now I cannot prove this BUT Duct Tape is called DUCT TAPE as it is used in repairing and closing and sealing heating and A/C DUCTS.

I have never seen any recalls of duct tape as any health risk.

Duct tape, per se, hasn't been used as hvac duct sealant by reputable companies in years.  It has been known to break down and disintegrate, thus leading to leaks.  Foil tape has been the preferred choice (speaking as a retired west coast house builder).  Some duct tapes even advertise it as for holding for temporary repairs.  I would hate to breath in disintegrating duct tape --  but imo, by the time that happens, the machine will probably be broken down, or it's owner passed away by then.