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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
[*** All web-site links removed by poster to ensure board rules compliancy. ***]


FDA Warning
Date Issued: June 30, 2021

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled
Due to Potential Health Risks: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks.

The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway.  If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021.


Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers

Talk to your health care provider to decide on a suitable treatment for your condition, which may include:

(1) Stopping use of your device

(2) Using another similar device that is not part of the recall

(3) Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.

(4) Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.

(5) Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

(6) Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may worsen the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.

(7) Register your device(s) on Philips Respironics’ recall to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA is requiring.

(8) Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.
[*** removed web-link ***]


PE-PUR Foam May Be Inhaled or Swallowed, Presenting a Potential Health Risk

Polyester-based polyurethane (PE-PUR) is a sound abatement foam used to reduce sound and vibration in these devices and other medical equipment. The PE-PUR foam in the affected Philips Respironics CPAP, BiPAP, and ventilator devices may:

(1) Break down (degrade) into particles which may enter the device’s air pathway and be inhaled or swallowed by the user

(2) Release certain chemicals into the device’s air pathway, which may be inhaled

These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.

To date, Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked.

The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.

The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.

The foam degradation may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone.  To date, there have been no reports of death as a result of these issues.


FDA Actions

The FDA is working with Philips Respironics to evaluate the issue, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by the company.

[*** "Philips' "corrective actions" to-date refers to requesting user device registration details. ***]

The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue.

The FDA does not have evidence at this time that any other CPAP machines, BiPAP machines, or ventilators, from Philips or other manufacturers, are affected.

The FDA will continue to monitor supply and demand to assess availability of the affected devices and any potential shortages.

The FDA will continue to share updates with the public as we learn more.


Reporting Problems with Your Device

If you think you had a problem with a CPAP, BiPAP, or mechanical ventilator, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.  

[*** web-link removed ***]
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
There is a lot of discussion here that is very superfluous, what kind of foam is it ,what are the machines have that foam, who is suing who, how do I fix the machine etc. etc. etc.

I think only one thing is important to understand and that is that the medical industry; the DME’s, docs and philips are NOT going to sort this out with any reasonable amount of time, and people are gonna be left for months without a machine. It’s time to find out where you can buy another brand, and go get it. Whatever that costs (unless it goes to thousands of dollars).After that you can sit back and ruminate over all these other ancillary discussions, but not now. People are going to be in trouble real soon if they don’t get back on a machine.

Just my opin….
Glen in Ft Lauderdale

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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Just a reminder that our rules prohibit most kinds of commercial links within the primary content of this forum (in forum posts) [see forum rules for details].

Web links that lead to, or are owned/operated by  a commercial law office website are prohibited under this rule.

You can mention the lawsuit case number, the name of the firm, the name of a website, etc. as long as their is no direct link or attempt to by-pass this rule by spelling out all or part of a web address like "Please visit my-online-store.com" or "Go to my-products-online-dot-com".  URL shortening services or other links that automatically re-direct to such prohibited sites are also not allowed.

By helping to keep most commercial links off the content of forum posts, you're helping us maintain our "educational organization" status, which helps us claim "Fair Use" Copyright Law exemptions so that we can freely distribute copyrighted Clinician Manuals without fear of lawsuits -- and yes, we have been threatened with a lawsuit over this, so this is what we've been advised to do by an attorney who is helping us.  Thanks for everyone's help in this - I greatly appreciate it.   Coffee
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-03-2021, 11:48 AM)WakeUpTime Wrote: FDA Warning
Date Issued: June 30, 2021

Nice job again; I just signed up to receive FDA email alerts. The downside that I see is that you might not show serious symptoms for years. You might have one of the recalled products, but if you do not have any side effects or your machine is not showing any forms of degrading the FDA can't help you. Which is my current status. I prefer to be here and have my health than to worry about lawsuits or what Philips might or might not do.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-03-2021, 02:30 PM)btreger Wrote: Nice job again; I just signed up to receive FDA email alerts. The downside that I see is that you might not show serious symptoms for years. You might have one of the recalled products, but if you do not have any side effects or your machine is not showing any forms of degrading the FDA can't help you. Which is my current status. I prefer to be here and have my health than to worry about lawsuits or what Philips might or might not do.

The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue. This was issued by the FDA on June 30, 2021, as you stated in your post. This is 12 years that Philips had to continue manufacturing their defective machines, and for customers to purchase them. It looks to me like Philips issued their Involuntary Recall on June 14, 2021, and only then did the FDA get involved. Not the other way around.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-03-2021, 04:12 PM)btreger Wrote: The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue. This was issued by the FDA on June 30, 2021, as you stated in your post. This is 12 years that Philips had to continue manufacturing their defective machines, and for customers to purchase them. It looks to me like Philips issued their Involuntary Recall on June 14, 2021, and only then did the FDA get involved. Not the other way around.

For many years, I have been signed up for -- and have received -- FDA Safety Alerts and Recall notifications. The emails, which arrive almost every weekday, are mostly about medications, implantable cardiac devices, and contaminated food products. 

I did receive the notice the FDA sent out on June 16, 2021, which followed the earlier stories in the press and recall notification from Philips Respironics, but I have not yet received the June 30, 2021 notice posted earlier today in this thread. I just checked my list of email subscriptions on the fda.gov website but everything seems in order. And I was able to find the June 30 notification, which was much more comprehensive than their June 16 alert, by doing a search on the FDA website. 

Does anyone who received the June 30 bulletin from FDA have any tips about the specific subscription you used to sign up for the email you received regarding the PR recall, among the list of many possible subscriptions on the FDA website? I, for one -- and I suspect many others following this thread -- would like to ensure that I do not miss any future FDA notifications about these devices.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
So glad I switched out my Dreamstation for the Resmed Autoset 10 1.5 yrs ago. It is a much better machine in all respects.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I’ve been thinking that in terms of a relatively quick solution, someone could do a 3D model of the DreamStation part containing the sound abatement foam, replacing the foam with a baffle that’d be a rough equivalent. Then, potentially the whole thing could be 3D printed. The part would have to be printed with a material that’d be safe to push air past, with no significant VOC content. Even knowing just the basics about 3D printing, this sounds feasible. I’m not in a position to push this due to my current health, but wanted to throw it out at least for discussion.
Geoffrey Rush as Philip Henslowe, (Shakespeare in Love) "I don't know. It's a mystery."
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I just received this email from the DME I have previously done business with;

SoClean 40% off sale

SoClean Cleaner & Sanitizing Machine
  • Destroys 99.9% of bacteria, viruses, and mold
  • Cleans your mask headgear, tubing, and water chamber in as little as 10 minutes
  • Uses ozone instead of water to sanitize equipment
  • Completely automated
  • 2-year warranty
I do not know how many complaints it would take to get the FDA to start reviewing this line of products. Especially after the major manufacturers of CPAP machines have already issued dire warnings.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-05-2021, 09:17 AM)btreger Wrote: I just received this email from the DME I have previously done business with;

SoClean 40% off sale

SoClean Cleaner & Sanitizing Machine
  • Destroys 99.9% of bacteria, viruses, and mold
  • Cleans your mask headgear, tubing, and water chamber in as little as 10 minutes
  • Uses ozone instead of water to sanitize equipment
  • Completely automated
  • 2-year warranty
I do not know how many complaints it would take to get the FDA to start reviewing this line of products. Especially after the major manufacturers of CPAP machines have already issued dire warnings.

[Image: attachment.php?aid=33473]

*With thanks RayBee


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