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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(05-24-2022, 02:37 PM)Dog Slobber Wrote: Could you please quote the statement within the article supporting your allegation the respironics machines killed 124 people.

Considering the respironics machines were illegally labelled and marketed as class II medical devices the onus will be on respironics to prove themselves innocent. Federal Judges will ultimately decide if selling a machine that exposes people to known carcinogens is/was a bad thing. 


Do the Recalled Philips CPAP Machines Cause Cancer?
When Philips first announced the CPAP recall in June, it took the scientific and medical community by surprise. As a result, there was nothing in the way of research or clinical studies establishing a specific causal relationship between prolonged use of the recalled CPAP devices and specific types of cancer or other medical conditions.

Philips performed its own internal lab testing and research prior to issuing the recall and essentially admitted that inhaling the foam particles could lead to cancer. In its June 14, 2021, recall notice, Philips stated that inhalation of the PE-PUR foam in the recalled CPAP devices could cause “possible toxic and carcinogenic effects.”

Philips also issued a brief report titled “Clinical Information for Physicians.” In this report, Philips disclosed that “[l]ab analysis of the degraded foam reveals the presence of potentially harmful chemicals.” The potentially harmful chemicals in the CPAP foam included 4 chemicals that are classified by the CDC as potential or known human carcinogens:

  • Toluene diamine: classified by the CDC as a “potential occupational carcinogen” and animal testing has linked to liver cancer.

  • Toluene diisocyanate: classified by the CDC as a “potential occupational carcinogen” and animal testing has linked to liver pancreatic, liver, and skin cancer.

  • Phenol: a possible carcinogen that is known to cause damage to the kidneys and liver.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
That looks like it's off a lawyers website. I would like to see up to date independent studies . Regardless I hope the ppl at Phillips behind this fiasco are all charged and incarcerated
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
DutchNews.nl


Philips shows ‘substantial’ shortcomings in sleep apnea recall

Medical technology group Philips has shown ‘substantial and structural’ shortcomings in its recall campaign for faulty sleep apnea technology, Dutch health service inspectors have told television current affairs to show Nieuwsuur.

In particular, patients, doctors and others involved in the sleep apnea treatment should have been better informed about the recall and the health risks posed by using the apparatus, the inspectors say.

Monique Klaaver, a lung specialist, told Nieuwsuur that Philips’ communication with doctors and patients is ‘deplorable’. ‘We are talking about an essential medical aid here, not a vacuum cleaner,’ she said.

Philips shows 'substantial' shortcomings in sleep apnea recall - DutchNews.nl
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
HME News


THE SLEEP INDUSTRY GRAPPLES WITH SHORTAGES

While supply chain delays have been a major chokepoint for the U.S. economy over the past year, the recall of Philips Respironics’ flow generators and masks has compounded the obstruction in the sleep therapy market. The ensuing vacuum created by the recall caused a ripple effect throughout the marketplace, causing various suppliers to scramble for ways to cover the shortage. 

“The recall has created a tremendous backlog regarding new patients’ access to PAP therapy,” said Ray Gregg, vice president of sales and business development for Livingston, Tenn.-based Encore Health. “Regional suppliers have projected eight-to-12 months to catch up on the backlog. Even once PAP availability normalizes, backlogs of this magnitude will take some time to work through to normalize the overall referral-setup pipeline.” 

Sleep industry grapples with shortages | HME News
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PHILIPS CORPORATE
(05-27-2022, 08:31 AM)btreger Wrote: Philips’ communication with doctors and patients is ‘deplorable’. ‘We are talking about an essential medical aid here, not a vacuum cleaner,’ she said.

Philips mass-marketed PAP devices in the same way that it marketed its toothbrushes.  They threw free products and volume discounts at the industry recommenders and authorized dealers.  Users assumed that their sleep centers and DMEs knew what was best for their health.  There was such premeditated bias along with no industry oversight.  

There's also no oversight into the effectiveness of the Recall, with everyone relying on quarterly statements coming out of the Philips Public Relations department.  It's painful to see Philips allowed to merely attempt to fix 90% of faulty devices within 1.5 years.  Further, no one will audit that the remaining 10% after 2022 isn't really more like 30%.  No one will hold Philips accountable for replacing ALL faulty products, not just those which Philips 'feels' deserving of a fix/replacment.  Lastly, Philips will continue to shield itself with 'supply chain shortages', although they were aware of its faulty foam for (at least) a couple years.

It's incredible that more medical specialists aren't speaking out against Philips.  They're all assuming Philips must be continuing to take care of things.  Meanwhile, Philips' PR department will continue to push out e-mails and press releases continuing to thank everyone for their patience, trust and understanding.

Now, wherever I see the 'Philips' brand, I continue to remind myself that there's the company that is taking two years+ to replace the carcinogenic foam in medically necessary patient devices.  While they make statements about being caring, quality-focused and trustworthy, time continues to prove the opposite of all these qualities.

I hope that next month, one year after the start of the Recall registration, the mainstream press will publish articles that state that millions continue to await fixes/replacements one year later.  Those articles need to remind prospective future Philips medical device users and buyers of the true nature of the Philips brand name.
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RE: PHILIPS CORPORATE
(05-27-2022, 12:44 PM)WakeUpTime Wrote: Now, wherever I see the 'Philips' brand, I continue to remind myself that there's the company that is taking two years+ to replace the carcinogenic foam in medically necessary patient devices.  While they make statements about being caring, quality-focused and trustworthy, time continues to prove the opposite of all these qualities.

I hope that next month, one year after the start of the Recall registration, the mainstream press will publish articles that state that millions continue to await fixes/replacements one year later.  Those articles need to remind prospective future Philips medical device users (and company buyers) of the true nature of the Philips brand name.

All so very true. WakeUpTime has been reminding us all for over a year now of the ongoing health care failings and the effects this is having on their customers. All the while without showing any signs of regret or remorse.

Then you run across an article like this:

yahoo/finance

Philips receives FDA 510(k) clearance for the latest breakthrough high-performance MR 7700 system

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, announced it has received FDA 510(k) clearance for the company’s new MR 7700 3.0T MR system.

This latest breakthrough MR innovation from Philips delivers unmatched performance and precision for both research and advanced clinical diagnostics, helping to address the Quadruple Aim. The XP gradients of MR 7700 provide high accuracy to support a confident diagnosis for every patient with Philips’ highest quality diffusion imaging [2] and advanced neuroscience, supporting improved patient care and lower costs.

MR 7700 expands scanning capabilities with a fully integrated multi-nuclei imaging and spectroscopy solution to explore new clinical pathways, without sacrificing clinical imaging workflow or wide-bore patient comfort, to enhance the experience of both staff and patients.

Philips receives FDA 510(k) clearance for the latest breakthrough high-performance MR 7700 system (yahoo.com)
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Netherlands Critical of Philips Responsiveness
(05-27-2022, 08:31 AM)btreger Wrote: Philips shows ‘substantial’ shortcomings in sleep apnea recall
Philips shows 'substantial' shortcomings in sleep apnea recall - DutchNews.nl

It's ironic that we have to get updated media stories out of the Netherlands regarding Philips lack of responsiveness on the Recall.  If only the U.S. media would analyze Philips' Recall effectiveness to-date.

Philips dropped the ball in sleep apnea machine recall: Inspectorate
https://nltimes.nl/2022/05/26/philips-dr...spectorate

Quote:Initial data showed that people breathing or ingesting the foam particles could lead to health problems like headaches, asthma, organ damage, and carcinogens. Philips later released more reassuring interim research results saying that the gases released were in such a low concentration that they fall within the safety standards. Philips published the interim results but not the underlying reports.

Last week, the United States' inspectorate, the FDA, said that it had received 21,000 health reports from users of the recalled Philips devices. These included reports of cancer, pneumonia, headache, dizziness, and chest pain.
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Philips Restricts Interviews
Philips doesn't want to be interviewed in a Q&A format on the Recall.  They insist on merely pushing out periodic Press Releases.  

FDA Releases Philips Recall FAQ - MAY 30, 2022
https://medtruth.com/articles/fda-regula...ecall-faq/

Quote:The FDA's Center for Devices and Radiological Health (CDRH) sent a notice to Philips Respironics proposing an order should be issued to require the company to submit a plan for the repair, replacement, or refund of all recalled devices manufactured after November 2015.

Philips Respironics was given an opportunity to request an informal hearing on this matter but declined, stating instead that it will provide a written response to the agency.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(05-25-2022, 04:37 PM)Vice Wrote: That looks like it's off a lawyers website. I would like to see up to date independent studies . Regardless I hope the ppl at Phillips behind this fiasco are all charged and incarcerated

Don't hold your breath waiting to see any positive, accurate, independent, test data from philips respironics.  If they had it they would have plopped it onto the table already, long before they started shoveling $2B or more into the dumpster fire known as the dreamstation recall and litigation charges. 

Nobody will get charged with a crime. They 'retired' a few select scapegoats (albeit guilty as hell scapegoats) and the FDA will buy off on the 'few bad actors' narrative. Case closed, let the buyer beware - FDA approved does not mean safe by any means.
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ONE YEAR LATER
"Millions of sleep apnea machines are still recalled. What should patients do now?"
https://www.sacbee.com/news/article262120997.html
The Sacramento Bee - June 6, 2022

Quote:A year after a massive recall affecting millions of Philips sleep apnea machines, people are still waiting for replacements or repairs. Some are using the machines in spite of the health risks that got them recalled in the first place.

Users venting in online support groups are angry that their machines have not been replaced or repaired yet. “Even though Philips’ recommendation is to stop using the equipment, there are no currently available replacement filters or other ‘quick fixes,’” says an explanation on The University of Kansas Health System website. KU advises patients to contact their medical equipment provider for alternatives.


"Johnson County man says he got lung cancer from CPAP sleep apnea machine"
https://www.kansascity.com/news/business...23372.html
Kansas City Star - June 6, 2022

Quote:A Prairie Village man has sued Philips over a continuous positive airway pressure (CPAP) machine he used for several years before developing lung cancer. The machine is the subject of a massive, ongoing worldwide recall of breathing devices used by sleep apnea patients.  The Johnson County man blames his sleep apnea machine for giving him lung cancer and is suing the manufacturer, which last year recalled the machine and several other breathing-aid devices.

It accuses Philips of knowing about the problems with the machines before last year’s recall and failing to warn users of a defect “that created a significantly increased risk of cancer, among other health impacts.” The company also failed to warn doctors who recommended the machines to their patients, the suit says. 

Philips does not comment on litigation, Mario Fante, senior press officer in the company’s global press office, said in an email to The Star. The recall is massive, involving as many as 3 million to 4 million devices worldwide, according to the company. The FDA defined it as a Class 1 recall, the most serious category for products that can lead to possible serious injury or death.
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