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

[WakeUpTime]

One would think that any device chamber with forced air under significant and varying pressures would be thoroughly analyzed and long-term tested under a variety of conditions, with significant extremes, to ensure that no component could be dislodged or broken down and transported into a patient's body.

That condition should be priority #1 before any other device function. It's unbelievable that the manufacturer, medical agencies, and consumer protection agencies never thought how extremely important that general principle would be. If Philips in its DS2, or any other ventilator manufacturer, should still not be meeting that basic requirement, significantly more trouble is ahead for the industry.

[DaveCar]

" It's unbelievable that the manufacturer, medical agencies, and consumer protection agencies never thought.. "

It seems that the latter two considered the former's initial testing and reporting on the safety of it's devices to be accurate.   Even now, after the news is fully up front, those organizations appear to be moving slowly.  What was that animated movie where the DMV was staffed entirely by sloths ?  

[btreger]

MEDTECHDIVE

Philips sleep apnea, ventilator recall triggers US lawmaker scrutiny, legal woes
Published Aug. 27, 2021, • Updated Aug. 28 2021, 9:42 a.m. EDT

Separately, a letter to Vitor Rocha, CEO of Philips North America from Sen. Richard Blumenthal, D-Conn. demands information on how many patients are impacted by the recall, how many have been given repair kits and been contacted by Philips, and the company's "timeline for submitting a mitigation plan with sufficient evidence to [the Food and Drug Administration] for authorization of a permanent solution."

The senator, who also asks why the delay from April to June on taking action, is requesting that Philips provide a list of information regarding the recall and impact on patients by Sept. 7. The list includes information on how Philips is reaching affected patients, the percentage of impacted patients that have had their recalled devices replaced or repaired, and when the company plans to have all affected devices replaced or repaired, among others.

The letter follows reports of patients who require the devices facing health risks as they have few replacement options and some who were not notified of the recall by the company.

"I have heard from a number of my constituents in Connecticut with similar concerns, such as a lack of information from Philips, first learning about the recall second hand, and no help in accessing the promised replacements or repairs that Philips continues to reference," Blumenthal wrote. "The current situation is untenable, unacceptable, and must be immediately rectified."

A Philips spokesperson confirmed in an emailed statement that the company has received the senator’s letter and expects to respond by the requested time frame.

This story was updated to include a statement from Philips.

Note: I pulled this section out of the article because it concerns a US Senator
The full article is at:

Philips sleep apnea, ventilator recall triggers US lawmaker scrutiny, legal woes | MedTech Dive

[btreger]

More on Philips

CPAP Usage Worldwide

Philips' worldwide market share is at 37%. However, in the US., its market share is closer to 63%.

Per the ASAA it's estimated that one in 15 adults in the United States has obstructive sleep apnea, which equals around 18 million people. Approximately 80% of these people are undiagnosed.


That would leave 14,400,000 probably using some form of CPAP therapy.

If the numbers and my math is correct that would mean that 9,072,000 adults started this year using Philips CPAP machines.  

[ghstudio]

btreger

You are onto something  Clearly Philips is NOT doing the right things.  Also a possibility is that Philips is not sure what they want/need to do to minimize the effect of the design error/recall.  Therefore, they are slow-playing the whole thing.

My assumption is that Philips is dragging their feet so that they will have fewer machines to fix.....Medicare will replace any machine at 5 years....so the assumption is that you'll get a new machine.....and one less recall to fix.

They deserve a very large fine for what they are doing as well as the loss of any government business.  Not clear that the FDA shouldn't just prohibit the sale of their machines in the US....but of course, the other suppliers can't fill the demand.  My guess/hope is a large fine...in the $100M or higher range.....for complete lack of a plan to fix in a timely manner.

[DaveCar]

Three people on a fb page that Im on are claiming to have received a DS2 so far. First one was about a week ago.
Legit ? Seems to be, but who knows..

[StratCat48]

I for one don't want a DS2 as a replacement and not because of the lack of user access to the data. The physical design is poor with the hose out the front of the machine and the water tank removed from the rear. My current setup with a DS1 has the hose looping behind the headboard of the bed up to an overhead hook. The DS2 would need to be on my nightstand facing to the rear and then the display would be more difficult to read and even then the hose comes out straight rather than angled upward like the DS1 which works better with my overhead hook. If I don't change to a Resmed machine, I would much prefer the blower housing be replaced in my DS1, rather than get a DS2.

[Mustang 85]

Re Post #1334

btreger, your math is not correct.  According to the US Census data from 2019, there are currently 328,239,523 people in the US, of which 255,271,738 are adults (18 and older), 124,267,346 men and 131,004,392 women. According to UpToDate (an online medical textbook for physicians), about 15% of men and 5% of women have OSA (some estimates are higher depending on the definition of OSA used).  This results in a total of 25,190,322 adults (18,640,102 men and 6,550,220 women) in the US with OSA. If, as you say, 80% are undiagnosed, then there would be a total of 5,028,064 adults diagnosed with OSA that MAY be using some form of PAP therapy, and PR would be supplying machines to 63% of those, or 3,167,681 people. And this is a TOTAL number potentially using PAP machines currently, not just those started on PAP machines this year alone.

I think where you made your mistake is calculating the 80% figure as those using PAP, instead of 20%; if 80% are undiagnosed, that means they don't know they have OSA and thus aren't likely to be using any therapy devices.

As a physician, I can tell you with certainty that not every person diagnosed with OSA is using PAP therapy. A lot of people just won't adapt to wearing that mask at night. So PR estimate of 3-4 million devices in the US is probably fairly accurate, if not a little high.

[Nella]

I'm glad to hear that someone in Congress has taken action. I reached out to my Congresswoman, Rep. Barbara Lee. While the staff person who followed up seemed very concerned and interested in taking action, I haven't heard back, but will try again and mention this action taken by the Senator. Maybe they can get some traction on this.

[Nella]

I'm brand new to this forum and first want to thank you all for running it. What a great resource.

I knew nothing about the recall until I happened to see the NY Times article. My Dreamstation is one of the recalled machines. Frustrating and infuriating days followed, probably like so many others have experienced.

But! Feels like winning the CPAP lottery in that I managed to nab a new ResMed Airsense10, which arrived on Sat. I poked around a lot online and I believe it was from posts here that I learned how I can adjust the settings. Expect to hear back from the seller, but what I was able to sort out helped me get the best night of sleep I've had in a really long time and an AHI of .3. 

Given the distinct contrast in the air quality with the 10, I can't help but wonder if anyone is aware of any labs that can test a Dreamstation to determine that it is actually spewing out particulates & carcinogenic fumes.  I don't necessarily want to spend lots of time or money on that, but it would certainly be interesting to find such a resource and get that data. Maybe some of the law firms that are starting to organize cases have that kind of resource.

I spoke with Sokolove Law, but don't know if I'll move ahead with a case.