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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Gideon - 07-27-2021
Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. Note that this will do nothing for the off-gassing.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - StratCat48 - 07-27-2021
I was considering an inline bacterial filter, but I seen a few concerns that using one may affect the air flow rate (not pressure) and necessitate a tweak of the settings to compensate. Anyone know for sure if an inline filter can be used without a settings adjustment?
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - WakeUpTime - 07-27-2021
(07-27-2021, 05:50 PM)StratCat48 Wrote: I was considering an inline bacterial filter, but I seen a few concerns that using one may affect the air flow rate ...
There are several separate threads with some experienced poster comments that you may wish to 'reply' to:
- Recommend a bacterial filter? | Apnea Board
- bacteria filter question | Apnea Board
- Inline Filter Questions | Apnea Board
PHILIPS - REPAIR/REPLACEMENT UPDATE - WakeUpTime - 07-27-2021
Quote:Home Medical Equipment News
July 27, 2021
PHILIPS SAYS UPDATES ARE ‘IMMINENT’
COMPANY IS ON TRACK TO REMEDIATE RECALL WITHIN 12 MONTHS, OFFICIALS SAY
AMSTERDAM – Philips could hear back from the U.S. Food and Drug Administration in August about its plans to replace the foam in certain CPAP devices and ventilators.
Philips filed 806 [FDA] applications for corrections and removals with the FDA in June and CEO Frans van Houten said, based on prior experience, there’s typically an eight-week turnaround [for FDA approval].
van Houten said Philips expects to ramp up production of DreamStation 1 and DreamStation 2 devices, as well as repair kits, to 80,000 units per week in the fourth quarter, up from 50,000 in the third quarter and 30,000 before that.
“Now, if you multiply that times the number of weeks, then you get somewhere between 3.5 million to 4 million units, right, and hence the 12 months expected throughput time on this,” he said.
Philips is limited in how much it can increase production due to supply constraints, van Houten said.
“We would be able to go faster if we could get our hands on the scarce materials from some of our suppliers, so we have been helping our suppliers with mold capacity, etc., so that they can ramp up faster,” he said. “If we see they can go faster, then we aim to shorten the 12 months, if possible. It’s too early to speculate on that. But certainly, that would be our aim, because that’s better for patients and, obviously, the sooner we can resume sales, that’s better for our own business.”
Therefore the current estimate seems to be gaining 'new foam' FDA approval during the end of August - although Philips has submitted 806 separate FDA applications during peak vacation periods. That approval timeframe may be very optimistic. Hypothetically, the fix/replacement process can begin perhaps in September for some. Pending no significant additional "supply constraints" (which Philips has expressed is already a concern), the recall process might be completed by September 2022.
The Philips CEO is on record for saying the faulty foam system update is "imminent". The definition of "imminent" is "about to happen". One might expect that their Philips recalled device might be fixed/replaced in a week or two. However, when the the Philips CEO uses the word "imminent", he really means that the approval for the design will begin around the end of August, the fix/replacement program will begin afterwards and continue until the fall of 2022.
Question: The DreamStation 2 xPAP series devices have already been FDA approved and use a different foam. Then why hasn't Philips already been rapidly producing and replacing tens of thousands of recalled defective devices with DreamStation 2 systems each week since the April and June announcements?
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - hegel - 07-27-2021
My airsense 10 has an anti bacterial filter setting. I merely set AB filter to "on" and assume the machine makes necessary adjustments. I've used these filters when fires were inundating my city with smoke. I had no issues in terms of restricted flow from the machine, altho my DME advised me that AB filters probably make the machine work a bit harder.
These filters aren't that expensive and are readily available. When I was using mine with a humidifier I checked for mold growth. I didn't find any but I was changing them out every two weeks.
If I had a PR machine I would certainly use one to see if it's collecting black foam flakes if for nothing else. And even if it wasn't I'd use one until I had a new machine.
As for off-gassing: The Brits and Canadian health agencies are writing that their tests suggest that is largely an issue for the first 24 hours of use. I had a Foam Memory topper mattress that off gassed for several days and then stopped. some new carpets off gas (or anyway put out a chemical smell) for several days. It follows that the PR foam works something like that.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - JJJ - 07-27-2021
I got my DS BiPAP a year and a half ago, but about a year ago I bought a Resmed S9 ASV from Supplier #2 to keep by my recliner chair, as a backup, and for travel. The fellow at Supplier #2 (great people!) took some time to explain about a problem with the DS machines, that is, if you don't keep the filter hospital clean the airflow will be reduced and the motors are so weak that they will burn out in a few years. And the motor can't be swapped out because they are tied by the motor's serial number to the motherboard.
Last year after two weeks of smoke from local wildfires my filters were dark brown. I bought an amply supply and now replace them often, although I discovered that putting a dirty filter in the dishwasher's silverware tray does a great job.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - S. Manz - 07-27-2021
(07-27-2021, 02:45 PM)Gideon Wrote: Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. Note that this will do nothing for the off-gassing.
Great idea.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - racprops - 07-27-2021
(07-26-2021, 08:10 PM)SingingSam Wrote: "If enough people express interest I can start a thread about de-foaming the S1. I've already done the job and took pictures. It isn't difficult. Reassembly is a little tricky. I found a way that I think is easier and produced for me a better result than the utube video method posted by Nick from Australia. I mean that in a nice way. Nick is on our side, and I’m in his debt for showing the way.
After nearly 8 years and over 19,600 blower hours my blower unit is remarkably clean inside. Other than a thin layer of dust on part of the top surface, the foam's condition is good. I drew the foam to scale on a two dimensional CAD system. The size of the foam is about 18.27 square inches. The thickness is about 0-7/16 inches. The volume is about 7.99 cubic inches. The weight is about 1/4 ounce, although my old analog postage scale isn't very precise. It is cut foam, not molded or injected. The foam density is maybe 2-3 pounds. My scales aren't accurate enough to quantify the density accurately. My de-foamed ASV still produces 9.5 cm H20 (confirmed with a digital manometer), and there is no discernible change in the sound. But producing a constant 9.5 isn't hard work for an ASV.
Rich is correct that simply removing the foam is not a good solution. Among other things simple foam removal blinds OSCAR and SleepyHead to events. I can recognize some events in the Flow Rate Chart. The LCD reports AHI numbers whereas OSCAR and SleepyHead report 0.0. Yes, I know that the machine and softwares use different algorithms to identify events.
What really got my attention was the jump in AHI reported by the LCD this morning. The jump was caused by my changing the System One resistance from 0 to X1. I knew from the size of the jump that there had to have been a dozen or more AHI events last night. Sure enough, even a noob like me can spot some obvious ones in the Flow Rate Chart. I counted 16, and there probably are others I don’t recognize. But SleepyHead and OSCAR both reported 0.0 AHI."
I am a full time ASV user, and find I really need it for my Complex Apnaes.
I was the first person here to remove the foam and the first and darn near the only who studed the lay out before I did it.
My reports before and after have remained the same as they have all year and more or less as they have for my 8 years.
This has been fully covered here: http://www.apneaboard.com/forums/Thread-The-DreamStation-Foam-Removal-Thread
And here https://www.facebook.com/Coyle-Medical-speculations-105633598461353
I also had in my procession a ResMed AiCurve 10 ASV (stock) and used it for about 4 days and received nearly the same reports, just to check.
Changing the System Resistance has the effect of changing the air flow to your mask (at least when running as a ASV) and I found that running an Dreamstation ASV on zero cause the ASV machine to hunt wildly with its its flow going all over the place. I nearly returned it as faulty when I learned to set my machine FOR X1.
I do not thing this applies to a machine set for pure CPAP, a setting and type of machine I cannot stand.
Rich
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - racprops - 07-28-2021
It stuck in the back of my head: "If enough people express interest I can start a thread about de-foaming the S1. I've already done the job and took pictures. It isn't difficult. Reassembly is a little tricky. I found a way that I think is easier and produced for me a better result than the utube video method posted by Nick from Australia. I mean that in a nice way. Nick is on our side, and I’m in his debt for showing the way."
By an S1 I think you're talking about the older System Ones a 50 or 60 series.
If so there is a flaw a number of people missed.
A simple removal of the foam leaves the S1 air chamber open to drawing air from inside the case, which allows uncontroled air in bypassing the filter. The foam sealed the bottom of this open chamber.
On the other hand from the looks of the flow and pressure sensors, they are ALL located at the outlet just before the hook up of an air hose or the humidifier. So with the SI all sensor is done in one place.
With mine, I used a clean food-safe plastic sheet and a different foam to form an air-tight solid seal.
Rich
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SingingSam - 07-28-2021
"By an S1 I think you're talking about the older System Ones a 50 or 60 series."
Correct, I mean the System One. Mine is the 50 series.
"With mine, I used a clean food-safe plastic sheet and a different foam to form an air-tight solid seal."
In your facebook post you mention that you replaced the foam with a very dense foam to which you added a food safe plastic sheet. I'd like to know more about the foam and plastic sheet that you used. Brand names? Where you bought them?
Because my foam is not degraded by heat, humidity, ozone or UV light I have wondered if the particles might be contained at the source by either wrapping the foam with a food-safe cling wrap or placing a sheet of food-safe wax paper on top.
What concerns me about food-safe materials is that the digestive tract has very good defenses against pathogens whereas the respiratory system is not as well defended. What is safe for the belly may or may not be safe for the lungs.