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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Mandibular Advancement Devices
It's my understanding that dental devices don't apply to those with severe sleep apnea (only mild to moderate), so it's not an effective solution to most of those requiring replacement devices as a result of the Philips Recall of its carcenogenic foam devices.  

The MAD market seems to grow significantlhy each year as every dentist is a potential seller, it's an add-on product for existing customers, brings in new customers, and captures a wide range of potential customers from those that merely snore all the way up to those with moderate sleep apnea.

There are so many MAD devices now on the market.  An xPAP, through programming, has the flexibility to grow with you, and many can make adustments on their own.  MAD devices may require continual tinkering to get a person ramped up to the right size.  Dentists will say that, like braces, that's why they have to charge fees of $2,500-$6,500.  I wish there was something inbetween the $99 throw away devices, that need replacing every year anyway, and the expensive models.  

It would be nice to have a $500 MAD option for xPAP users that was high-quality, long-lasting, and user adjustable, that could be "for emergency use only" - power outages, short naps, etc.  But it would probably need FDA approval and, if dentists couldn't make a lot of money with it, they wouldn't recommend and promote it.

http://www.apneaboard.com/forums/Thread-...Mandibular
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Not sure what this means at this point... Dated March 10, 2022

Quote:FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines

Today, the U.S. Food and Drug Administration issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products, because the company’s notification efforts to date have been inadequate.[/color]

“The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Taking this action today enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.” 

The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the recalled products. The order also directs Philips to maintain language to patients regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall, and to provide instructions for device users to register their devices on the Philips website.

Along with these actions, the FDA recommends additional measures Philips can take to better communicate with the public regarding the recall. Specifically, the FDA recommends that Philips provide monthly updates to device users who register their devices on the Philips website that include information on expected time for replacement and current rate of replacement of recalled devices. The FDA also recommends that Philips provide detailed information to device users, DME suppliers, distributors, retailers, and healthcare providers on the replacement process.

In June 2021, Philips Respironics initiated a recall of certain ventilators, CPAP and BiPAP machines due to potential health risks related to PE-PUR sound abatement foam used in those devices. This particular foam may break down and can result in serious injury, which can be life-threatening, cause permanent impairment and/or require medical intervention to prevent permanent injury to users.

Since the initiation of the recall, the FDA has engaged with Philips on several fronts about the effectiveness of its communications with the public regarding the recall and the risks presented by the recalled products and has expressed concern that it is likely a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products.

The FDA is issuing this order under section 518(a)of the Federal Food, Drug, and Cosmetic Act. Under this authority, the FDA may order a manufacturer to provide notification if the FDA determines that a device presents an “unreasonable risk of substantial harm to the public health” and such notification is necessary to “eliminate the unreasonable risk of such harm and no more practical means are available [under the Federal Food, Drug, and Cosmetic Act] to eliminate such risk.” The FDA may order that adequate notification be provided to device users, health care providers who prescribe or use the device, and any other person who should receive notification to eliminate such risk.

The order directs Philips to provide the notification described in the order within 45 days of its issuance.

Source: https://www.fda.gov/news-events/press-an...assistance
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I read this FDA statement also.  From my understanding, Phillips did not satisfy the FDA with it's communication and likely with the slow rollout of replacements.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Not sure if right Forum to post this in, but...I just got a replacement DreamStation2 machine in the mail, today (Saturday, 3/12/2022).
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Avign0n323.......

How long did it take to get the replacement after you registered (when did you register the recalled machine) and did the recalled machine originally come from a DME?

My replacement DS2 came in 3 months after my recalled DS1 was registered. I somehow feel the DME was involved to get the replacement in the short time that I did, as they had all the information (serial number, etc) on the replacement when I received it.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I registered on 7/15/2021 and it originally came from a DME back in 2017. The replacement DS2 came straight from Philips.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
My neighbor (the guy who grew up in MY house) received a DS2 earlier this week. We had been talking off-and-on about the recall since last summer. I was the one who told him about it. He was using a DS1 at the time.

We have the same pulmonologist and my neighbor had an at-home sleep study done last fall and the pulmo wrote him a new script for a replacement machine. However, due to the DME not being able to provide one in a timely manner, my neighbor bought one (a ResMed) from an online supplier.

So now he has a new DS2 that he'll likely only use as a backup, and he's planning on returning his DS1.

Meanwhile, I have 3 machines on recall and nothing yet. GRRR. To be fair, I do have a DS2 that I purchased on my own about a week before the recall was announced.
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Dreamstation Go replacement?
I saw on a FB group this morning that someone was looking to purchase a DS Go. 

I mentioned that I was pretty sure that they knew it was recalled, and that I had one (not for sale).

Someone else responded that they had received their DS Go replacement 2 months ago and that it was a new one.

This is the first time that I've seen/heard about anyone getting a DS Go replacement as part of the recall. Has anyone else heard of this before? It does give me some hope about my DS Go. I've been wondering what Philips will be doing with those machines since a DS2 isn't a real replacement option...since they were purchased to be used as travel machines.
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RE: Dreamstation Go replacement?
(03-13-2022, 01:55 PM)chasmm Wrote: This is the first time that I've seen/heard about anyone getting a DS Go replacement as part of the recall. Has anyone else heard of this before? It does give me some hope about my DS Go. I've been wondering what Philips will be doing with those machines since a DS2 isn't a real replacement option...since they were purchased to be used as travel machines.

I have one that was registered as soon as their website was up and running. I have not heard anything about a replacement. I received the same e-mail notifications that I am registered and in their system.
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RE: Update on Philips recall portal
(03-09-2022, 11:14 AM)chasmm Wrote: I'm not sure if this has been mentioned, but the Philips portal has some additional (at least to my knowledge) info available.  

The quality of Philips' response to their Recall, almost one year continues to be annoying...

Quote:Prioritization information
If you need to change this information, please call INSERT NUMBER.

"INSERT NUMBER" never supplied.  Nice coding quality.  We must continually remind ourselves that end-users are not Philips' customers.  To Philips, we are their customers' customers, and their communications to end-users are generally there by force, mandate or regulatory pressures.  No doubt, the efforts of class-action lawyers also helps.
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