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

[btreger]

WTMJ-TV
MILWAUKEE

The I-Team reached out to Philips asking several questions ( 1.) This massive recall happened in June. Why are consumers still waiting for answers from Philips? 2.) Has Philips replaced or repaired any of the machines yet? If so, how many? 3.) How much longer do consumers impacted have to wait? 4.) Has Philips been notified of any consumers who have become ill or injured from any of the recalled devices?)

Philips responded via email with the below statement:


In relation to your question on the recall notification process, in accordance with medical device regulations and laws in the markets that we serve, Philips is required to broadly communicate a notice of this kind at the earliest possible date. This is intended to ensure wide and timely awareness of potential safety issues as well as important instructions related to the clinical use of affected devices.

We have launched a comprehensive patient and customer communication program, which includes dedicated mailings, call centers, and websites in more than 100 countries. This is a complex undertaking and patients may have learned about the recall notification via the news before they received the direct mailing/letters.

Philips often does not own or manage the patient's contact information – many patients purchase their devices through third parties. So this broad approach was the fastest way to inform patients of this issue. Philips is working with those third parties (Durable Medical Equipment providers - DMEs) to also reach patients directly as quickly as possible. We are working around the clock to continue to reach out to our customers and patients.

In relation to your query on how Philips is addressing affected devices, we have mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. We fully understand the impact that this is having on patients, as their well-being is at the heart of everything we do at Philips.

Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam. The repair and replacement program will be at no cost to consumers in the U.S. Philips has taken a EUR 500 million provision to pay for this repair and replacement program.

Regarding the estimated timing of the field actions, we are working to address this issue as expeditiously as possible. However, given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.), we expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances. The company is therefore in consultation with regulatory authorities worldwide regarding the correction program. Philips also continues to monitor and analyze reports of complaints with affected devices, in accordance with our Quality Management System and post-market surveillance activities.

At this time, Philips is already producing repair kits and replacement devices in large quantities. We have increased the production capacity of repair kits and replacement devices in the third quarter of 2021 to 55,000/week and we aim to further increase that capacity to 80,000 units/week in the fourth quarter of 2021. As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients.
We are requesting that patients with affected devices currently in use register their products on our dedicated website to facilitate repair. Registration is what formally starts the repair/replacement process.

If a Durable Medical Equipment provider (DME) registers a product for a patient, the DME will manage the replacement process and be in contact regarding the status and expected time frame. If a patient registers their product, Philips and the DME will consult to determine which organization will manage the replacement process. If the DME authorizes Philips to perform the replacement, Philips will be in contact regarding the status and expected time frame. This process is necessary to move forward and may take some time.

Philips continues to recommend that affected patients please follow the advice of their physicians, as they are most familiar with a patient's medical history. To aid the clinician in the consultation with the patient, Philips has made the following clinical information available: Information for Physicians and other medical care providers
We will continue to publish updates at the following dedicated website for the recall.

Philips provides an update on recall notification - News | Philips [philips.com]


Sincere regards,
Mario Fante
Senior Press Officer
Philips Global Press Office

[mrmagloo]

Interesting that just the other day they were saying they were waiting on repair kit approvals, but today, they are already producing large quantities? I also noted the part about a "NEW Foam". Based on the reports from the folks who have removed the foam from their units, you would think that most folks would prefer the replacement kits not to have foam. Seems most people would rather live with an extra db in machine sound than risk another foam deterioration scenario down the road, toxic or not.

The more I'm hearing, the more I think I just want to opt out and just remove the foam myself. The prospects of getting stuck with a new DS2 or a different rebuild with unknown hours with this new foam, is not exactly a soothing thought. I dunno?

[josedeca]

I've received a notice about this recall from Phillips, on page: Atualização de cuidados respiratórios e do sono | Philips (http://www.phillips.com.br/healthcare/e/...#section_3).
[url=https://www.philips.com.br/healthcare/e/sleep/communications/src-update#section_3][/url]
I will call the given SAC phone 0800 707 6767 to see how are my options in the recall.
I am very happy on seeing that Phillips is taking seriously the recall here in Brazil.

[btreger]

This is a question for the many users who have taken their machines apart and done work on them. Philips keeps saying they are producing "Repair Kits". I cannot picture what that may look like, considering the very specific problem we have, foam.

So if anyone has an idea what a repair kit is, please respond.

Thank you

[SingingSam]

"...we expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances."

btreger, thank you for the news article. The quote above from Philips is the first official indication I've seen concerning when the 12 month period begins.

For users in the USA, it does not begin until the FDA approves the resolutions that Philips proposes which vary from model to model.

Regarding the contents of repair kits, I can't think of anything System One machines really need other than a safe version of the foam and maybe a disposable wipe for interior cleaning.

[SingingSam]

I saw my sleep doctor this morning. When I showed him diffusers with black spots he commented that some of his ResMed patients have shown him the same thing.

A closer view with a microscope probably would help discern between foam particles and other sources of indoor pollution such as candles. Wildfires aren't common in my area, but the Jet Stream sometimes delivers wildfire smoke from distant places.

The central SA I had 8 years ago is gone. I'll update my profile after my new machine arrives.

The doctor prescribed a ResMed AirSense 11 AutoSet, so I'm a happy camper.

[btreger]

KAKEabcCOM


Recall: Philips Respironics CPAP, BiPAP, and Ventilators

Here are some answers to frequently asked questions related to this recall.

Q: I use one of the affected devices daily. I can’t wait for a new device. What can I do now?

A: The FDA has provided recommendations for people who use an affected device in its safety communication, Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks, including that you may continue to use your affected device if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

You may also read the FDA’s consumer update, Always Tired? You May Have Sleep Apnea, which includes updates on obstructive sleep apnea treatments.

Additionally, the FDA is engaging professional societies and patient advocacy groups to help connect sleep and dental professionals and patients with information regarding alternative treatment options for obstructive sleep apnea.

Q: When a medical device is recalled, what is the FDA’s role?

A: When the FDA learns of a company’s correction or removal action, it reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the product, determines if the problem is in violation of the Federal Food, Drug, and Cosmetic Act or otherwise fails to comply with FDA requirements, and, if appropriate, assigns the recall a classification (I, II, or III) to indicate the relative degree of risk. After the recall is classified, the FDA monitors the recall to ensure that the recall strategy has been effective.

For the Philips Respironics recall, the FDA has identified this as a Class I recall, the most serious type of recall, and is continuing to work with the company to assure it has sufficient evidence to support the Philips Respironics recall strategy, including its corrective actions. The FDA will continue to monitor the company’s recall.


Q: Philips Respironics has stated they “will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances.” Is the FDA reviewing Philips Respironic's submission for clearance of the new foam?

A: As the medical device manufacturer, Philips Respironics has a responsibility not only to ensure the manufacture of safe and effective devices but also to establish an appropriate mitigation strategy to reduce public harm in the event of device failure or defect.

The FDA is reviewing the information Philips Respironics has provided regarding replacement devices while continuing to work with Philips Respironics on their corrective actions for existing devices. As the FDA reviews this information, the FDA will determine whether the proposed replacement devices pose any additional risk to people who use these devices.

Q: I understand the sound abatement foam may be causing the problems related to the recall. Should I try and remove the foam from my device?

A: No. The FDA recommends that you do not remove the sound abatement foam, as it may impact device performance and possibly introduce foam debris into the device.

Q: Who is responsible for correcting the issue with the affected Philips Respironics devices?

A: The recalling firm, Philips Respironics, is responsible for correcting the issue and developing a recall strategy that takes into account the following factors as they apply to this particular recall:

• Results of health hazard evaluation.
  
• Ease in identifying the product.
  
• The degree to which the product's deficiency is obvious to the consumer or user.
  
• The degree to which the product remains unused in the marketplace.
  
• The continued availability of essential products.
  

The FDA is reviewing the adequacy of Philips Respironics’ proposed recall strategy as it becomes available from Philips and is recommending changes as appropriate.

Q: What else can the FDA require Philips Respironics to do to correct the affected devices?


A: The FDA can use advisory actions, administrative actions, and enforcement actions when a firm’s voluntary action is not rapid or complete, or when the firm is uncooperative.

Q: Should I expect any notification from Philips Respironics?

A: The FDA recommends you register your device on Philips Respironics’ recall websiteExternal Link Disclaimer is to stay informed of updates from Philips Respironics about any new instructions or other corrective actions required by the FDA.

Q: I have registered my recalled device on Philips’ website. What should I expect now?

A: The FDA is working with Philips Respironics to assure the company sufficiently evaluates the device problems, the scope of the recall, and the most appropriate mitigation strategies, including adequate corrective actions by the company. The FDA will continue to share updates with the public as new information becomes available.

Q: What should I do if I am unable to register my device on Philip’s website?

A: For more information or help with the registration external Link Disclaimer process, please call Philips Respironics at 877-907-7508, as indicated on their website. The website provides you the instructions on how to locate your device Serial Number for the registration.

Q: Can I be reimbursed for the cost of a replacement device?

A: Please contact Philips RespironicsExternal Link Disclaimer as indicated on their website.

Q: If I obtain a new CPAP machine, what should I do with my recalled device?


A: Contact Philips RespironicsExternal Link Disclaimer or your health care provider for information on your local Philips Respironics representative to receive instructions and directions on how to return your recalled device(s). Do not discard or recycle the recalled device.

Sorry, just adding to the list of available documents:

[WakeUpTime]

The foam repair process, for the estimated 2M recalled device users who are getting "fixes" rather than replacements, is going to be a bottleneck.  How is Philips going to deal with users, who desperately/medically must use their devices, not having them for perhaps 2-3 weeks (including all shipping times)?  Will a truck driver or pilot need to take that time off work?  Many haven't bought into "all you need is a bacteria filter".  Many are continuing to use their devices as-is.  In fact, agencies such as the U.S. VA, with a massive recalled xPAP user base, has continued to promote merely continuing to use recalled devices (with side-notes and exceptions of course).

The more lucky ones will get fixes perhaps 1-2 months after the FDA approval.  Others around the world might be still waiting, well after 12 months, as they might not even have service centers in their region.  It wouldn't matter to me if Philips already had 2M packaged pieces of foam in inventory.  It's the service process that's going to be challenging and, no doubt, full of hiccups.  Yes, I know, there will be some that will say "it only takes 10 minutes to replace the foam".  But let's think of all the other steps and logistics involved.

The user has to first package and ship their device to their country's service depot.  The tech may have to run a test on arrivals, because they'll want to be sure that they have a functioning device to begin with.  Then they'll have to end with a full test procedure.  We all know that, with all the shipping in, wire and board manipulations, and shipping out, there are going to be end-user arrivals that won't work as indicated.  Let's never forgot: We're talking about repairing a prescribed medical device rather than merely a mechanical consumer product.  Philips will have to be extremely careful what they ship back out, and what the end-user ultimately receives.  

In the U.S. alone, they'll need several hundred techs.  I seriously doubt that those centers will be staffed to the maximum, working 3 x 8-hour shifts, 7-days a week.  The priority of users will be interesting too.  They likely won't be going merely in order of registration dates, as there are so many other factors to consider (end-user vs. hospital/agency/etc., machine type, SoClean use, etc.).

Once the first few users in social media report that Philips repaired their machine, that's when the calls to Philips' contracted telemarketing center will magnify significantly.  In the mean time, let's see what regional and country judgements come out that may also significantly influence Philips' scheduling and procedural priorities.

[Zalagar]

Philips keeps saying they are producing "Repair Kits". I cannot picture what that may look like, considering the very specific problem we have, foam.

So if anyone has an idea what a repair kit is, please respond.

From what has been speculated, it is just the exact same blower housing chamber that's in our DS 1's currently, just with the new white foam from the DS 2. As you can see in the video I will link below, the DS 2 blower chamber is pretty much identical to the DS 1's, even has foam in similar spots. They will most likely swap the chamber, blow out the turbine in the blower fan, and re-assemble it and shoot it back to us. It would be cool if they replace the blowers as well, but that would be pricey for them, so who knows.

Video Link to the Dreamstation 2 Disassembly Video: https://youtu.be/QsN9TBvVMhc?t=147

[Zalagar]

Here is also a foam comparison between the Dreamstation One/System One, Dreamstation Two, and the ResMed Airsense 10 when exposed to Ozone and how it reacts.

https://youtu.be/DbHcZUFRDqg