Phillips / Philips Respironics recent recall notice discussion thread

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
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JLROhio
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by JLROhio » Fri Jun 25, 2021 2:45 pm

ChicagoGranny wrote:
Fri Jun 25, 2021 12:01 pm
JLROhio wrote:
Fri Jun 25, 2021 10:08 am
Can you post some pics?
----------------> https://www.youtube.com/watch?v=SQnJAF3bm98
Thanks...the more info the better!
* This is the internet - what I write will probably NOT come across as it would in person; where one can read a person's face.
My posts are sometimes tongue & cheek w/some snarky sarcasm mixed in.
I leave it up to you to figure it out!
:wink:

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JLROhio
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by JLROhio » Fri Jun 25, 2021 2:55 pm

Here are the US Congressional committees within the House of Representatives and the Senate that oversee the FDA.
If one of these reps in Congress is in your district...you should consider reaching out to their office and get them to be concerned about this Phillips recall and ask if your member plans to bring Phillips in for a Congressional Hearing to discuss this recall and more importantly the unanswered health matters. Congress has lots of hearings - some important, some not so important...I would think that a recall involving 4 million CPAP units would be considered important to a member of Congress. As a bonus, if your member of Congress is not really that important - this might be the issue they are looking for to give them a bump up in stature within Congress.

US House of Representatives - The Committee on Energy and Commerce - Health Subcommittee
https://energycommerce.house.gov/subcom ... h-congress
https://twitter.com/EnergyCommerce

CHAIRWOMAN - Anna G. Eshoo California ~ 18
G. K. Butterfield North Carolina ~ 01
Doris O. Matsui California ~ 06
Kathy Castor Florida ~ 14
John P. Sarbanes Maryland ~ 03
Peter Welch Vermont ~ 00
Kurt Schrader Oregon ~ 05
Tony Cárdenas California ~ 29
Raul Ruiz California ~ 36
Debbie Dingell Michigan ~ 12
Ann M. Kuster New Hampshire ~ 02
Robin L. Kelly Illinois ~ 02
Nanette Diaz Barragán California ~ 44
Lisa Blunt Rochester - Delaware ~ 00
Angie Craig Minnesota ~ 02
Kim Schrier Washington ~ 08
Lori Trahan Massachusetts ~ 03
Lizzie Fletcher Texas ~ 07
Frank Pallone, Jr. New Jersey ~ 06

Brett Guthrie Kentucky ~ 02
Fred Upton Michigan ~ 06
Michael C. Burgess Texas ~ 26
H. Morgan Griffith Virginia ~ 09
Gus M. Bilirakis Florida ~ 12
Billy Long Missouri ~ 07
Larry Bucshon Indiana ~ 08
Markwayne Mullin Oklahoma ~ 02
Richard Hudson - North Carolina ~ 08
Earl L. "Buddy" Carter Georgia ~ 01
Neal P. Dunn Florida ~ 02
John R. Curtis Utah ~ 03
Dan Crenshaw Texas ~ 02
John Joyce Pennsylvania ~ 13
Cathy McMorris Rodgers Washington ~ 05

----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----

US Senate - Committee on Health, Education, Labor and Pensions (HELP)
https://www.help.senate.gov/

Patty Murray (WA)
Bernie Sanders (VT)
Robert P. Casey, Jr (PA)
Tammy Baldwin (WI)
Christopher S. Murphy (CT)
Tim Kaine (VA)
Maggie Hassan (NH)
Tina Smith (MN)
Jacky Rosen (NV)
Ben Ray Luján (NM)
John Hickenlooper (CO)
Richard Burr (NC)
Rand Paul (KY)
Susan Collins (ME)
Bill Cassidy, M.D. (LA)
Lisa Murkowski (AK)
Mike Braun (IN)
Roger Marshall (KS)
Tim Scott (SC)
Mitt Romney (UT)
Tommy Tuberville (AL)
Jerry Moran (Kansas)

----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- ----- -----

And just so everyone is aware before you reach out to your Congress Critter...You should ALSO know how much money they took from Phillips in the last report on Campaign contributions by Phillips to Congress critters!

https://www.opensecrets.org/political-a ... ients/2020
* This is the internet - what I write will probably NOT come across as it would in person; where one can read a person's face.
My posts are sometimes tongue & cheek w/some snarky sarcasm mixed in.
I leave it up to you to figure it out!
:wink:

--

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Pugsy
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Pugsy » Sat Jun 26, 2021 9:15 am

JLROhio wrote:
Fri Jun 25, 2021 2:21 pm
Maybe the report should have its own sticky...and not be stuck here on page 25 of this thread!
I am not going to give it a separate sticky but I did put the 2 links you posted in as additional information in the sticky #2 that no one can post in but me to keep down on the clutter. So they are in a sticky that I imagine people will be reading or at least seeing.
Plus I added "additional information" to the topic.

As far as your comments about contacting your elected representatives....sorry but I had to snort a bit on that one.
My personal opinion is that most of them are as useless as teats on a boar hog and they won't do a damn thing unless you happen to have one of them who actually is using a Phillips machine.

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SleepyCPAP
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by SleepyCPAP » Sat Jun 26, 2021 9:16 am

Thanks all for help in thinking about the recall. I have a System One 450, and a System One 460. Both are in the recall group, both are now registered.
Some of you are asking about “Q Series”. Unless you’ve looked at a System One circuit board you would never have seen that company designation.

I’ve put one of those in-line bacteria filters between my hose and the mask. I see Pugsy says to look for a setting change, I’ll have to think whether System One machines have that. I’ll see if any bits show up on the media.

As far as off-gassing, didn’t we also have a scare about the BPH plastic on the original humidifier tanks?

I’ve been using CPAP (my 450) since 2010, I figure every breath has been a life-saver, no matter what mixed with the air. I’m glad I lived to see my children grow up, graduate, etc. Back when I was first diagnosed in 2010 I remember I felt as if I could die at any time, that’s how bad I’d been worn down by non-treatment. I even bought the extended warranty for the new washer before I got my CPAP, thinking I wouldn’t be around to repair it in future years and my wife would be able to have repairs done for her. And I never buy extended warranties! (I outlived the big box store that sold it, and the 2010 washer got upgraded this year). No matter what I’ve been breathing through my mask, I’m still here. I’m not going to discontinue use while things are figured out. Besides, I’ve aged a bit - losing my hair on top, but growing extra out of my nostrils - such unsightly hairs probably caught bits if there were any. I’ll remember not to trim them until my machine gets fixed :lol:

_________________
Machine: AirCurve™ 10 VAuto BiLevel Machine with HumidAir™ Heated Humidifier
Mask: Bleep DreamPort CPAP Mask Solution
Additional Comments: Use OSCAR. Combine AlaxoStent with VAuto for perfect 0.0 AHI at PS 3.6 over 4cm EPAP
-- SleepyCPAP
Sleep study in 2010 (11cm CPAP). Pillows (Swift FX>TAP PAP >Bleep). PRS1 “Pro” 450/460 until recall, now Aircurve 10 VAuto. Tape mouth. Palatal Prolapse solved by AlaxoStent & VAuto EPAP 4cm, PS 3.6cm = 0.0 AHI

Dan_McD
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Dan_McD » Sat Jun 26, 2021 11:40 am

SleepyCPAP wrote:
Sat Jun 26, 2021 9:16 am
Thanks all for help in thinking about the recall. I have a System One 450, and a System One 460. Both are in the recall group, both are now registered.
Some of you are asking about “Q Series”. Unless you’ve looked at a System One circuit board you would never have seen that company designation.

I’ve put one of those in-line bacteria filters between my hose and the mask. I see Pugsy says to look for a setting change, I’ll have to think whether System One machines have that. I’ll see if any bits show up on the media.

As far as off-gassing, didn’t we also have a scare about the BPH plastic on the original humidifier tanks?

I’ve been using CPAP (my 450) since 2010, I figure every breath has been a life-saver, no matter what mixed with the air. I’m glad I lived to see my children grow up, graduate, etc. Back when I was first diagnosed in 2010 I remember I felt as if I could die at any time, that’s how bad I’d been worn down by non-treatment. I even bought the extended warranty for the new washer before I got my CPAP, thinking I wouldn’t be around to repair it in future years and my wife would be able to have repairs done for her. And I never buy extended warranties! (I outlived the big box store that sold it, and the 2010 washer got upgraded this year). No matter what I’ve been breathing through my mask, I’m still here. I’m not going to discontinue use while things are figured out. Besides, I’ve aged a bit - losing my hair on top, but growing extra out of my nostrils - such unsightly hairs probably caught bits if there were any. I’ll remember not to trim them until my machine gets fixed :lol:
I'm glad you are thankful for your health longevity. Everyone has differing experiences, conclusions, and opinions. I used a Dreamstation for a little over 2 1/2 years. The last year my nose and throat irritation has gotten worse. It has been difficult to say the least to get a night of sleep without interruptions. I'm not one to usually panic by something I read on the internet, but this recall upset me enough to order a new ResMed 10. While I have only used it for 2 nights (I set up the machine myself), It has been an improvement over the Dreamstation. Last night was the first night of uninterrupted sleep that I can remember for some time. No dry mouth or irritations. Per the machine timing, I slept for 6 hours and 58 minutes. I had one blockage and could see the jump in pressure to diffuse the breathing interruption (total apnea) 00:00:34 seconds. This recall as of right now, has been a blessing in disguise for me. Not to argue, but from what I have read and the videos I have watched, you probably will not see foam pieces in your tube or mask. The real danger of the Dreamstation are the 3 chemicals (off-gassing) and the VOC's that the machine emits. To make things worse, it is likely that Philips has been well aware of these defects for some time. Given my options, I would rather not take the chance of inhaling those chemicals. I am so thankful for this website/forum or I would not have know about the recall.

EDIT: To correct total Apnea.

_________________
Machine: DreamStation Auto CPAP Machine
Mask: Simplus Full Face CPAP Mask with Headgear
Humidifier: DreamStation Heated Humidifier
Additional Comments: Quattro FX, 1L Everflo Q Concentrator, OSCAR Software - Q-Mirage as back-up
Last edited by Dan_McD on Sun Jun 27, 2021 6:52 am, edited 1 time in total.

Dan_McD
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Dan_McD » Sat Jun 26, 2021 11:58 am

SleepyCPAP wrote:
Sat Jun 26, 2021 9:16 am
Thanks all for help in thinking about the recall. I have a System One 450, and a System One 460. Both are in the recall group, both are now registered.
Some of you are asking about “Q Series”. Unless you’ve looked at a System One circuit board you would never have seen that company designation.

I’ve put one of those in-line bacteria filters between my hose and the mask. I see Pugsy says to look for a setting change, I’ll have to think whether System One machines have that. I’ll see if any bits show up on the media.

As far as off-gassing, didn’t we also have a scare about the BPH plastic on the original humidifier tanks?

I’ve been using CPAP (my 450) since 2010, I figure every breath has been a life-saver, no matter what mixed with the air. I’m glad I lived to see my children grow up, graduate, etc. Back when I was first diagnosed in 2010 I remember I felt as if I could die at any time, that’s how bad I’d been worn down by non-treatment. I even bought the extended warranty for the new washer before I got my CPAP, thinking I wouldn’t be around to repair it in future years and my wife would be able to have repairs done for her. And I never buy extended warranties! (I outlived the big box store that sold it, and the 2010 washer got upgraded this year). No matter what I’ve been breathing through my mask, I’m still here. I’m not going to discontinue use while things are figured out. Besides, I’ve aged a bit - losing my hair on top, but growing extra out of my nostrils - such unsightly hairs probably caught bits if there were any. I’ll remember not to trim them until my machine gets fixed :lol:
I'm glad you are thankful for your health longevity. Everyone has differing experiences, conclusions, and opinions. I used a Dreamstation for a little over 2 1/2 years. The last year my nose and throat irritation has gotten worse. It has been difficult to say the least to get a night of sleep without interruptions. I'm not one to usually panic by something I read on the internet, but this recall upset me enough to order a new ResMed 10. While I have only used it for 2 nights (I set up the machine myself), It has been an improvement over the Dreamstation. Last night was the first night of uninterrupted sleep that I can remember for some time. No dry mouth or irritations. Per the machine timing, I slept for 6 hours and 58 minutes. I had one obstruction and could see the jump in pressure to diffuse the breathing interruption (total time in apnea) 00:00:34 seconds - AHI 0.45. This recall as of right now, has been a blessing in disguise for me. Not to argue, but from what I have read and the videos I have watched, you probably will not see foam pieces in your tube or mask. The real danger of the Dreamstation are the 3 chemicals (off-gassing) and the VOC's that the machine emits. To make things worse, it is likely that Philips has been well aware of these defects for some time. Given my options, I would rather not take the chance of inhaling those chemicals. I am so thankful for this website/forum or I would not have known about the recall.

EDIT: To correct total Apnea.

_________________
Machine: DreamStation Auto CPAP Machine
Mask: Simplus Full Face CPAP Mask with Headgear
Humidifier: DreamStation Heated Humidifier
Additional Comments: Quattro FX, 1L Everflo Q Concentrator, OSCAR Software - Q-Mirage as back-up
Last edited by Dan_McD on Sat Jun 26, 2021 5:31 pm, edited 1 time in total.

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JLROhio
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by JLROhio » Sat Jun 26, 2021 12:43 pm

Pugsy wrote:
Sat Jun 26, 2021 9:15 am
JLROhio wrote:
Fri Jun 25, 2021 2:21 pm
Maybe the report should have its own sticky...and not be stuck here on page 25 of this thread!
I am not going to give it a separate sticky but I did put the 2 links you posted in as additional information in the sticky #2 that no one can post in but me to keep down on the clutter. So they are in a sticky that I imagine people will be reading or at least seeing.
Plus I added "additional information" to the topic.

As far as your comments about contacting your elected representatives....sorry but I had to snort a bit on that one.
My personal opinion is that most of them are as useless as teats on a boar hog and they won't do a damn thing unless you happen to have one of them who actually is using a Phillips machine.
Perfect on posting the links - that's the perfect place! Thanks!

As to the comment about the politicians - that's very, very, very fair...considering most of them are from the swine family! :lol: :lol:
But you're correct if any of them are using a Phillips machine...I wonder how they're feeling now - of course, they probably have a health care plan that allows them instant access to a ResMed replacement.

Again though...if a few of us poke their office staff with a phone call - AND double whammy if they are on one of these committees that oversee the FDA - this is a HUGE recall and should be affecting a LOT of constituents/VOTERS. I wonder if there is a map or study somewhere that shows CPAP issuance/usage per state. I'm sure that Phillips and ResMed have that data based upon their own distribution metrics.
* This is the internet - what I write will probably NOT come across as it would in person; where one can read a person's face.
My posts are sometimes tongue & cheek w/some snarky sarcasm mixed in.
I leave it up to you to figure it out!
:wink:

--

Grumpy48
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Grumpy48 » Sat Jun 26, 2021 2:04 pm

FDA links which outlines the guidelines for a recall. The Philips recall is voluntary and presumably would follow FDA Title 21 CFR 7

Specific to medical devices......
https://www.fda.gov/medical-devices/pos ... ls-devices
Title 21 CFR 7........
https://www.accessdata.fda.gov/scripts/ ... ?CFRPart=7

Not sure how much clout this organization may have, but this was an interesting statement
"The letter also requests that CMS provide flexibility to allow and cover the costs of replacing recalled devices during the 5-year reasonable useful lifetime. According to the letter, DME suppliers should be allowed to repair or replace the recalled equipment without requiring documentation of a new clinical evaluation, sleep test or trial period, and patients should not be responsible for the repair or replacement costs."
https://aasm.org/aasm-advocates-payers- ... ap-recall/

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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Pesser » Sat Jun 26, 2021 2:16 pm

reader2580 wrote:
Mon Jun 21, 2021 8:41 pm
Philips is in no danger of going under due to this. Annual revenue is over $20 billion.
I think "Respironics" is a subsidiary of Philips. This has all the markings of a company wanting to get out of this business and closing the lawsuits behind it. If the sub isn't selling to a third party and Philips wants out; this is one way to do this. There is something behind this and I think it is serious. They are re-calling every machine (almost). The System One had no problems!!!

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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Pesser » Sat Jun 26, 2021 2:33 pm

palerider wrote:
Tue Jun 15, 2021 9:05 pm
Pugsy wrote:
Tue Jun 15, 2021 4:52 am
I am still trying to figure out what "Q" series means since this is the first time we've seen this
Maybe it stands for "Quit using these" :lol: :lol: :lol:
Palerider, a few years ago explained the wonderful advantage of having a Resmed. Well I just paid for one and waiting delivery. Palerider has won this argument.

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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by zonker » Sat Jun 26, 2021 3:43 pm

Pesser wrote:
Sat Jun 26, 2021 2:33 pm
palerider wrote:
Tue Jun 15, 2021 9:05 pm
Pugsy wrote:
Tue Jun 15, 2021 4:52 am
I am still trying to figure out what "Q" series means since this is the first time we've seen this
Maybe it stands for "Quit using these" :lol: :lol: :lol:
Palerider, a few years ago explained the wonderful advantage of having a Resmed. Well I just paid for one and waiting delivery. Palerider has won this argument.
not a lot of people would admit that.
:wink:
people say i'm self absorbed.
but that's enough about them.
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by zonker » Sat Jun 26, 2021 3:58 pm

forum friend lane101 posts this in a different thread-
Lane101 wrote:
Sat Jun 26, 2021 1:26 pm

P.S. I called the Phillips 1-877 number yesterday. Pending regulatory approval they can't provide any additional information on recall next steps and timing beyond registration of our affected machines.
so there's that. the ps is because he has a longer post that tells us about the foam. see that thread here-

http://cpaptalk.com/viewtopic/t182292/C ... -Risk.html
people say i'm self absorbed.
but that's enough about them.
Oscar-Win
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by Dan_McD » Sat Jun 26, 2021 5:55 pm

JLROhio wrote:
Sat Jun 26, 2021 12:43 pm
Pugsy wrote:
Sat Jun 26, 2021 9:15 am
JLROhio wrote:
Fri Jun 25, 2021 2:21 pm
Maybe the report should have its own sticky...and not be stuck here on page 25 of this thread!
I am not going to give it a separate sticky but I did put the 2 links you posted in as additional information in the sticky #2 that no one can post in but me to keep down on the clutter. So they are in a sticky that I imagine people will be reading or at least seeing.
Plus I added "additional information" to the topic.

As far as your comments about contacting your elected representatives....sorry but I had to snort a bit on that one.
My personal opinion is that most of them are as useless as teats on a boar hog and they won't do a damn thing unless you happen to have one of them who actually is using a Phillips machine.
Perfect on posting the links - that's the perfect place! Thanks!

As to the comment about the politicians - that's very, very, very fair...considering most of them are from the swine family! :lol: :lol:
But you're correct if any of them are using a Phillips machine...I wonder how they're feeling now - of course, they probably have a health care plan that allows them instant access to a ResMed replacement.

Again though...if a few of us poke their office staff with a phone call - AND double whammy if they are on one of these committees that oversee the FDA - this is a HUGE recall and should be affecting a LOT of constituents/VOTERS. I wonder if there is a map or study somewhere that shows CPAP issuance/usage per state. I'm sure that Phillips and ResMed have that data based upon their own distribution metrics.
There is no doubt there are a lot of corrupt representatives and do nothing politicians. The House Congressman from my district Jason Smith, is not one of them. I had one heck of a fiasco with SSA and Disability in particular, related to my adult disabled son. I contacted my Congressman and he immediately contacted SSA and stuck with us ( 3 years) to get a well deserved approval from SSA disability. We were dealing with tons of forms, doctors, denials, appeal councils and appellant judges. If it had not been for Congressman Smith I know SSA would have told us to shove it. Thing is, this was not a handout or a gift. My son worked for 33 years and he and his employer paid into FICA, like all of us do, until he became disabled.

Not all politicians are empty suits. At least my Congressman isn't. Just felt I needed to say this. Sorry if it offended anyone. I meant no harm.

_________________
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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by ChicagoGranny » Sat Jun 26, 2021 6:18 pm

Of course, his staff did all the work. If he made a call, it was to one of the staff in his office.

In a case like your son's, do they get all the back checks from the time of filing? Surely so.

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Re: Sticky: Phillips Respironics recent recall notice discussion thread

Post by georgep » Sat Jun 26, 2021 6:46 pm

I got my System One in February of 2016 and it's in the recall. Philips says it will take "some time" to replace. They are saying to stop using the machine. I'm not sure what they expect us to do. I hardly sleep at all without it.

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