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

[btreger]

 I truly hope for everyone's sake you get better results in your quest.  I know for fact, it will just about take an act of God to answer the question you are posing. I admire your tenacity, so please don't misread my comments as ridiculing, which was a totally incorrect read there. I agree with all else in your last post.

I accept your response and thank you for your comments.

[btreger]

I accept your response and thank you for your comments.

I think we should all try to do something, unfortunately, I do not know the answer. I do know that 12 years from now, I do not want to have to live through this again, for maybe the next time it could be even worse.

Come to think about it, I do have a few thoughts:

1. The FDA needs to change the way manufactures can put new products on the marketplace. Today the FDA relies solely on the manufactures own reports. Third-party clinical medical reports need to be summited along with any other paperwork. The manufactures must pay for the clinical reports and cannot pick who does them.
   
2. I know we have some users in Australia. It might be interesting to know if you are receiving new DS2's, and how is your Medical Agency dealing currently with all that is happening right now?    
   

[btreger]

RE: >Post 1345<

Maybe I am being too suspicious, but in that post, Sen. Richard Blumenthal told Philips he wanted answers to very specific questions by Sept.07. 

On that date is when we first started hearing about DS2 deliveries. Is that just a coincidence, or did the Senator's demands force Philips into its current actions without having a complete plan or strategy?

I know no one has that answer, but I think it is worth considering. Especially since we have no other information to go by.      

[Zalagar]

I saw people stating they were receiving DS2's well before September 7th. But before then I had only seen around 3 people that had gotten them, at least ones that had posted about it. It definitely picked up a lot more over time.

[Zalagar]

I just signed into the DreamMapper app for the first time since 2016, re-connected my machine and let it upload the data. Hoping that is the secret. MY uncle is stuck using his DS1 with the stupid in-line filters and he hates it, but he has to have his machine. He got his machine in like January of this year, but for some reason, his insurance won't let him swap to a new machine... I don't want to take the foam out and possibly void the warranty or prevent replacement for him. I'm hoping I can either get a DS2 or a repaired machine for him soon. My Brother in Nevada is still using his Remstar Auto with his SoClean every single day also, he had no clue about the recall, when I went to visit him, I made sure to register his machine, but sadly his will probably take months to replace

[Zalagar]

I've also been trying to swap to a Resmed AirSense 10 or 11 as soon as possible, my machine is over 5 years old, I had to get a new sleep study, it has now been almost a full month since the sleep study and my doctor still hasn't gotten the results yet. Not sure if it is a staffing issue or why it is taking so long. The sleep center is the same company as my Doctors office, the data is shared, so not sure why they haven't input the data. So it's been around 2 months now I've been trying to get a new machine, still waiting, it's very frustrating. My Doctor just told me to keep using my DS1 until I can get a new one, he said "You've already been using your machine for 5 Years, what's another 1-2 months?"...

[btreger]

NEW UPDATE FROM THE FDA:

Q: When will the devices start to be repaired or replaced? (New 9/10/21)
A: Philips Respironics announced external Link Disclaimer on September 1, 2021, “Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices” and “intends to complete the repair and replacement programs within approximately 12 months.”

Q: What is the status of Philips Respironics’ plans for repairing or replacing the devices? (New 9/10/21)
Philips Respironics’ implementation of a plan to fix the problems with the Philips Respironics products is a high priority for the FDA. The FDA reviewed and concurred with Philips’ Respironics plan for recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto (All Configurations), Dream Station BiPAP; Pro, Auto (All Configurations), and DreamStation ST, ASV, AVAPS (All Configurations).

The FDA is committed to using every tool at our disposal to increase the availability of these medical products. The FDA is working with Philips Respironics to monitor the repair or replacement of impacted devices as expeditiously as possible and is continuing to gather information to inform our actions. We are collaborating with other manufacturers and government partners to support the availability of CPAP and BiPAP machines.

Philips Respironics has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace products across all the Philips Respironics’ recalled devices, including the Trilogy ventilators, A-series BiPAP machines, C-series BiPAP machines, OmniLab Advanced+, Garbin Plus, Aeris, LifeVen, E30 ventilator, REMstar SE Auto, and E30.

The FDA has also initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements. 

You can read the full statement at this link;

Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions | FDA

[btreger]

 I had to get a new sleep study, it has now been almost a full month since the sleep study and my doctor still hasn't gotten the results yet. 

Can you explain why you had to get a new sleep study? You own the machine after 5 years, and your doctor gets the reports of your daily use. Is it an insurance issue or a pass the buck situation.

[WakeUpTime]

[FDA]  "Philips Respironics has not yet provided the FDA with all the information needed for the FDA
to evaluate the plan to repair and replace products across all the Philips Respironics’ recalled devices,
including ... A-series BiPAP machines, C-series BiPAP machines, ...REMstar SE Auto."

That's incredibly bad news for non-DreamStation owners.  For those of us with these recalled devices, that have been inhaling/ingesting the old decomposing carcinogenic faulty foam for the longest period of time, we'll likely be waiting a significant period of time for a fix.

Maybe I am being too suspicious, but in that post, Sen. Richard Blumenthal told Philips he wanted answers to very specific questions by Sept.07. 
On that date is when we first started hearing about DS2 deliveries. Is that just a coincidence, or did the Senator's demands force Philips into its current actions without having a complete plan or strategy?

It's my belief that every effort to put pressure on Philips has contributed (and will continue to contribute) to better outcomes for all recalled device owners.  Whether it's from your significant contributions, or those others who have done various things like calling their local Senator, reaching out to law firms, etc., it's going to continue to help make for quicker faster better outcomes.  I really commend those efforts as they went far beyond satisfying one's own personal interests.

[davepap]

FDA's filings for Philips Respironics 
https://fda.report/Company/Respironics-Inc


Respironics Inc
FDA Filings
This page includes the latest FDA filings for Respironics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Respironics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
Kevin Walls

All of Philips FDA filings seem to submitted with Kevin Walls of Regulatory Insight, Inc., possibly a former FDA employee who helps privately now helps medical companies get FDA approvals.

DeviceCompany Device Date
GUDID 00606959054165Respironics, Inc. BiPAP 312121 2021-08-25
GUDID 00606959062221Respironics, Inc. DreamStation ARX200H15C 2021-07-05
GUDID 00606959062849Respironics, Inc. DreamStation 2 BLX410H15C 2021-04-07
GUDID 00606959062832Respironics, Inc. DreamStation 2 BLX510H15C 2021-04-07
GUDID 00606959062825Respironics, Inc. DreamStation 2 BLX420H15C 2021-04-07
GUDID 00606959062818Respironics, Inc. DreamStation 2 BLX520H15C 2021-04-07
GUDID 00606959060524Respironics, Inc. BiPAP DEX2900S13 2021-03-29
GUDID 00606959059474Respironics, Inc. BiPAP BRX3000S18 2021-03-29
GUDID 00606959059450Respironics, Inc. BiPAP A40 EFL, AR ARX3000S19 2021-03-29
GUDID 00606959059443Respironics, Inc. BiPAP ARX3100S19 2021-03-29
GUDID 00606959062757Respironics, Inc. DreamStation 2 FRX521H14C 2021-03-15
GUDID 00606959062214Respironics, Inc. DreamStation Auto BiPAP wHumCell, LA LAX700H15C 2021-03-15
GUDID 00606959062207Respironics, Inc. DreamStation LAX600H15C 2021-03-15
GUDID 00606959054677Respironics, Inc. DreamStation 300723W 2021-02-12
GUDID 00606959062061Respironics, Inc. BiPAP SPX3100S19 2020-12-23
GUDID 00606959061316Respironics, Inc. DreamStation JPX501S16 2020-12-23
GUDID 00606959061231Respironics, Inc. BiPAP 1146885 2020-12-23
GUDID 00606959049147Respironics, Inc. DreamStation 100755W 2020-10-26
GUDID 00606959048768Respironics, Inc. BiPAP A30 1111144V 2020-10-26
GUDID 00606959048751Respironics, Inc. BiPAP A30 1111144M 2020-10-26
GUDID 00606959048744Respironics, Inc. BiPAP A30 1111144L 2020-10-26
GUDID 00606959048737Respironics, Inc. BiPAP A40 IT1111169 2020-10-26
GUDID 00606959048720Respironics, Inc. A Series, Sys One, Heater Hum IT1111552 2020-10-26
PMN K201439Respironics, Inc. Ventilator, Non-continuous (Respirator) 2020-09-25
PMN K200480Respironics, Inc. DreamStation 2 System, DreamStation 2 Advanced System 2020-07-10


At the bottom of the FDA filings page is a list of all Philips overseas large container shipments that have arrived in the U.S. The most recent is from September 27 2020 from China containing 3505 Kilograms. Looks to be only large cargo container shipments arriving by ship.

The following Bill of Lading record outlines a container shipment imported into the US by RESPIRONICS INC.. This shipment is registered as coming from INTERPLEX (SUZHOU) PRECISION ENGINE via Shanghai ,China (Mainland). Manifest records show a quantity of 135 CTN with a total weight of 3505 Kilograms arrived on 2020-09-27 via the vessel MSC DANIELA to the port of Long Beach, California. Cargo includes products identified as medical.