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

[WakeUpTime]

FD Netherlands (perhaps similar to the Wall Street Journal or the Financial Times) has interesting articles related to the Philips tag.  (https://fd.nl/tag/philips)  Regrettably, many NL news outlets are behind paywalls.  The following article titles are translated:

• "Top Woman Leaves Philips in Crisis" - June 8, 2022
  
• "Philips Replaces Top Quality Manager Amid Recall Crisis" - June 7, 2022
  
• "You Should Not Know This About Philips" - June 2, 2022
  
• "Philips Failed to Report Serious Issues to FDA for Years" - June 1, 2022
  
• "The Crisis List of Feike Sijbesma at Philips" - June 1, 2022
  
• "Insperctorate Lashes Out Against Philips for Apnea Surgery" - May 26, 2022
  
• "Market Watchdog Does Not Investigate Further Delivery Agreements for Philips Sleep Apnea Equipment" - May 20, 2022
  
• "Philips Problems are Much Bigger Than Its Bonus Policy" - May 19, 2022
  
• "Philips Sticks to Bonus for CEO Van Houten" - May 18, 2022
  
• "About Bonuses and Bizarre Motivations" - May 13, 2022
  
• "Nearly 80% of Philips Shareholders Oppose Bonus to Philips CEO" - May 10, 2022
  
• "Rebellion Against Millions of Bonuses at Philips" - May 6, 2022
  
• "Dutch Hospitals are Taking Measures to Continue Using Philips Devices" - May 1, 2022
  
• "Brittons Reports Deaths Due to Failure of Philips Devices" - April 20, 2022
  
• etc.
  

[TimaaaaaaaahRocks]

• "Nearly 80% of Philips Shareholders Oppose Bonus to Philips CEO" - May 10, 2022
  
• "Rebellion Against Millions of Bonuses at Philips" - May 6, 2022
  

Shareholders lose 55% of their stock value. Philips CEO Frans van Houten accepts a 1.8 million euro bonus, and the "board of directors is doing well".  I hope someone on the board of directors, upon receiving a bonus for 'doing well', had enough of a sense of humor to say out loud, "let them eat polyurethane foam dust!"

Philips shareholders voted overwhelmingly against Philips’ bonus policy. Several investors had previously indicated that they would vote against, because they did not accept the bonus of 1.8 million euros that Philips CEO Frans van Houten would receive.  Investors are dissatisfied with the company’s results. Philips has a problem with delivery issues and sleep apnea devices. The company launched a recall that cost about 900 million euros.  About 80% of the shareholders present at the annual meeting voted against. Votes are not binding. A Philips spokesperson said the bonuses have already been paid out and will not be canceled now. Commissioner Feike Sijbesma said after the vote: “We regret this result and take these comments seriously.” said. “I want to point out that the board of directors is also doing well, but we will continue to talk to shareholders next year,” he said.

[sawinglogz]

About 80% of the shareholders present at the annual meeting voted against. Votes are not binding. A Philips spokesperson said the bonuses have already been paid out and will not be canceled now.

This is why the stock is tanking.

When the shareholders (the actual owners of the company) are unable to assert control over a clearly negligent board of directors, you have no way of preserving your investment, so you get out.

[TimaaaaaaaahRocks]

This is why the stock is tanking.

When the shareholders (the actual owners of the company) are unable to assert control over a clearly negligent board of directors, you have no way of preserving your investment, so you get out.

But Frans van Houten, chief executive, told the Financial Times on Monday (Oct 2021) that the company had used the polyurethane foam in its respiratory devices for decades—meaning more than 10m had used the foam—arguing these met regulations at the time of production.

“We’ve been designing and producing ventilators for 10 to 20 years and we have been using this kind of foam forever. It was fully qualified by the rules, regulations, and standards at the time,” he said.

---

Shareholders make decisions based on public disclosures made by company directors. These public disclosures are obligated by law to be truthful. The FDA inspection report from Nov 2021 proves that Frans was either clueless as to how respironincs failed to adhere to FDA medical device regulations or he simply made false statements to the investment community. Comes down to what did he know and when did he know it? Nope. Ignorance of the facts does not exonerate a company director from their obligation to tell shareholders the truth. Frans was not aware that an engineer had reached out to the foam supplier? “this is not a good situation for our users.” It was also not a good situation for shareholders. Frans on the other hand got a 1.8 million euro bonus. This type of chicanery undermines the integrity of our capital markets.

Anyone else wonder how many respironics employees, family, and friends unloaded their PHG positions prior to April 2021?

[WakeUpTime]

There were some interesting industry notes in this article:

(1) DMEs are requesting that the FDA grant an emergency order to rapidly approve xPAP systems not currently approved in the U.S.  I can't see the FDA being excited about that as they may see high risk in rapidly approving devices which may each have the possibility of future recalls.  The FDA likely also knows that they can pressure large multinational organizations who strongly desire continuation in the U.S. market.  Small providers would more likely shut down operations if faced with a major recall of this magnitude.

(2) The DME mentioned at least one xPAP manufacturer that, because of the chip shortage, has returned to shipping an SD-card-only device, without any cloud-based technology (less chips).  

"Managed Healthcare Magazine"
June 20, 2022
[Note:  Intentionally did not include the interviewed DME name as it wasn't important to the article.]

12 months on, the situation is still difficult.  “From an impact perspective, not much has gotten terribly better,” he said.  

Philips says it has produced 2.4 million repair kits and placement devices globally, and shipped 1.1 million replacement devices in the United States, but Mongeau said the shift of manufacturing resources toward the recall has created a supply squeeze.  “The big challenge is that half of the volume in the supply chain was gone with part of the recall, and then all of those resources were then put into the remediation—building new devices to then replace the old devices—and none of those were able to be sold into that market.”  Add to that the pandemic-related supply chain issues globally, and you have what Mongeau said amounts to “a double whammy against the industry.”

Patients who use Philips devices have a difficult decision to make. The American Academy of Sleep Medicine has encouraged providers to prescribe a different device, if feasible.

The recall and the rush to replace the devices has also created a shortage of the semiconductors necessary to build cloud-connected machines, prompting one rival manufacturer to begin re-marketing devices that use SD storage cards, which record data that then must be downloaded by the patient or a provider in order to get actionable insights.

In the meantime, he and others are hoping the FDA will grant emergency use authorizations (EUAs) to allow other devices into the US market on an emergency basis, similar to how the agency used its emergency powers to boost the supply of ventilators following the emergence of coronavirus disease 2019 (COVID-19).  “One of the things that we've asked the FDA for is to actually have an EUA specific to the CPAP shortage, as this is also a public health emergency,” he said.

Mongeau said such a move would likely result in an influx of new entrants into the US market.  “There are truly dozens of manufacturers globally that are selling into Europe and the Asia Pacific [markets] that just haven't entered the US market because of the barriers to entry in the US,” he said. “And if there was an EUA specific to CPAP and sleep apnea, that could be another option.”

“In the year that this has been going on, our demand has almost gone up threefold,” he said. “And so it's not slowing down.”

[WakeUpTime]

"These machines to help people breathe were recalled a year ago. Many still use them"
LA Times | June 23, 2022
https://www.latimes.com/california/story...pap-recall
or https://www.aol.com/news/machines-help-p...58294.html

Yet a year later, many patients are still awaiting replacements — and some are using the recalled machines despite those possible risks.  Coleman said her machine underwent some initial repairs, but she is seeking a new oneafter federal regulators sought more safety testing of the replacement foam used for such fixes.

The company said it expects to replace or repair roughly 5.5 million devices globally, the bulk of which are CPAP or BiPAP machines.

Tom Wilson, who administers a Facebook support group for CPAP users affected by the recall, said he has read comments from group members who say they haven't had any communication with Philips despite registering their devices with the company as much as a year ago. Some have paid out of pocket to get other devices.  "It becomes a choice between continuing to use a potentially cancer causing device or spending $1,000 or more, especially for those with severe obstructive sleep apnea," Wilson said in an email.

In New Jersey, Chloe Berger said she stopped using her CPAP machine and suffered debilitating migraines and exhaustion. "I couldn't maintain a job. I was just too tired," said Berger, 30, a therapist who said she had to give up one job, then another, because she was struggling to stay awake.

Berger said she paid out of pocket for a different machine in April, roughly two months before Philips sent her a replacement. Waiting had taken an emotional and mental toll on her, she said. "You feel like you're swimming upstream, and nothing is happening."

The massive recall has already spurred class-action lawsuits from users across the country.

"They've botched the whole thing," said Dena Young, senior counsel at Berger Montague, who said that most of the people represented by her firm had not gotten a replacement or repair. As they wait, "some of them are still using the Philips because they don't have a choice."

Federal investigatorshave also taken interest: In April, Philips said the U.S. Department of Justice had subpoenaed the companyin regards toevents leading to the recall.

The FDA's Center for Devices and Radiological Health told Philips last month that it was seeking to order the company to turn in a plan that could include not only repairing and replacing the recalled devices, but also providing refunds. In a November report, an FDA investigator found that Philips had failed to start taking appropriate action years earlier when the company first became aware the foam could be breaking down. Emails showed that the company was aware of “foam degradation issues” as early as October 2015, the FDA investigator found.

Within three years, more emails indicated that Philips had gotten more complaints about crumbling foam in ventilators and said that testing had confirmed that it broke down in high heat and high humidity, but the firm “made the decision not to change the design,” according to the FDA report in November. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as "contaminants, particles, foam, debris, airway, particulate, airpath and black."

Klink, the Philips spokesperson, said there had been "limited complaints" about foam breakdown in prior years that were assessed on "a case-by-case basis." He said the 220,000 complaints mentioned by the FDA were identified through "broad word searches" and that a company review found that a much smaller number — about 3% of them — were about alleged foam degradation. The company said that when its executive committee became aware of the issue and its possible significance early last year, it took "adequate actions" that led to the voluntary recall.

This year, the FDA found that Philips' efforts to alert patients were insufficient, concluding that many patients were probably still unaware of the health risks nine months after the recall had begun. In March, it ordered the company to notify health professionals, device distributors and users of the recalled machines after estimating that only 50% of patients and consumers who had gotten recalled CPAPs and BiPAPs within the last five years had registered with the company for a replacement.

In December, Philips said that its testing of one set of CPAP and BiPAP devices included in the recall found that the level of chemical emissions “is not typically anticipated to result in long-term health consequences for patients.”  That testing did not explore the health risks from ingesting bits of foam, however, nor did it lookat other devices covered by the recall. The Center for Devices and Radiological Health said in May that it was not convinced that such testing was enough to downgrade the estimated harm from the tested machines.

Concerns have continued to mount. From April 2021 through April 2022, federal regulators have gotten more than 21,000 reports about medical issues potentially tied to the recalled devices — or malfunctions likely to cause injuries if they recurred — including 124 reports linking them to deaths.Cancer has beena stated concern: Since 2020, more than 1,100 such reports about Philips CPAP or BiPAP machines have included the words "cancer," "tumor" or "tumour," said Madris Kinard, chief executive of Device Events, which gathers data to track problems with medical devices.  However, Zuckerman said "it's assumed that a lot of deaths and other serious injuries don't get reported at all."

..."I am so incredibly disappointed," he said, "at the lack of advocacy by anybody involved."

[Twiztidninja]

Hey guys! Just registered my device online a few days ago it finally posted to there site and I can see the portal. It says it takes a while and it will go through multiple stages but mine is already saying That a DME has been matched and on the top it shows prioritization added. Is that a sign mine got bumped up somehow or is that how everyone's looks? Has anyone in here actually gotten a replacement and if so how long from registration until you had your replacement.

Honestly I had no idea there was a recall until a couple days ago when I started googling because I was considering purchasing a new unit but if I can snag one for free then even better.

[btreger]

The Denver Gazette

These Machines to Help People Breathe were Recalled a year ago. Many still use them:

The danger of stopping a ventilator that sustains someone’s oxygen flow is evident. Even switching to a different model can be precarious. Halting recalled CPAP or BiPAP machines can also be “unacceptably risky” for certain patients, physicians warned in the American Journal of Respiratory and Critical Care Medicine.

Consumer safety advocates argue that the halting process underscores the shortcomings of the recall system, which relies heavily on private companies to inform consumers and take action.

“It isn’t actually easy for the FDA to take products off the market,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research center that has raised concerns about the safety of medical products. “It should be a lot easier than it is.”

But the actions the FDA has taken so far in the Philips recall also show that the agency “has more power in recalls than they usually use.

Within three years, more emails indicated that Philips had gotten more complaints about crumbling foam in ventilators and said that testing had confirmed that it broke down in high heat and high humidity. Still, the firm “made the decision not to change the design,” according to the FDA report in November. The FDA investigator noted that dating to 2008, Philips had gotten more than 222,000 consumer complaints that included keywords such as “contaminants, particles, foam, debris, airway, particulate, airpath, and black.”


These machines to help people breathe were recalled a year ago. Many still use them | U.S. & World | denvergazette.com

[hearsay73]

I got my replacement DS1 Auto Bipap the other day after registering last year.

 I had to send my previous DS1 Auto Bipap blower [which I have been using for 3 years], SD Card, Filters, and Power supply to a Philips authorized DME prior to receiving the replacement unit. I got a DS1 Auto Bipap blower unit, SD card, Filters, and a new unopened slim line hose in return. Considering that Philips has not released a DS2 Bipap, this seems to be the only option right now for DS1 Bipap owners.

From the looks of it, the replacement DS1 Bipap blower unit that I received is new, and not refurbished, with a manufacturing date of January 17, 2022. There is no “recertified” or “refurbished” label on it.

While the unit from the outside looks new, of course, I have no way of knowing if the innards of this unit i.e. blower and board etc. of this replacement unit is really new or was just pulled from another recalled DS1 machine.  Knowing how sketchy Philips has been during this whole recall, I wouldn’t be surprised if these are old parts just repackaged in a new case. Definitely, this will be my last Philips machine. I’ll be looking to replace this with ResMed in the future.

[JonC]

DreamStation Go Users

I just received this update from my DME, 

This is the Confirmation #provided to me by Philips.  It may just take some time to get these into their system and toes to the right people/companies.

On a related note, I can tell you Philips does not even have the FDA approval completed for the remediation process for the DreamStation Go.

I guess I'll continue to not attempt to rush things then.  I'd really like a Dreamstation Go as a replacement for my Dreamstation since at this point since I now have a couple AirSense 10s and I'd like to have a travel machine.

("Oh, you're not on CPAP any more and want me to wipe that machine's data card so you can get rid of it?  No problem.  I'll take care of the whole machine for you.")