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

[TimaaaaaaaahRocks]

yahoo/finance


Philips says tests on recalled ventilators are' very encouraging'

AMSTERDAM (Reuters) -Independent tests on ventilators that Dutch health technology company Philips recalled last year because of possible health risks showed the problems were almost exclusively caused by unauthorized cleaning products, the company said on Tuesday.

"Inspection of over 60,000 machines in the U.S. has shown foam degradation in less than 0.5% of the users of the machines said had not been cleaned with ozone," Van Houten told Reuters in a telephone interview.

"With the use of ozone products, this goes up to 7% or 14 times higher. The correlation between the use of ozone and foam degradation that we assumed last year has been proven."

Philips says tests on recalled ventilators 'very encouraging' (yahoo.com)

What's Van Houten's point: their %$#!!y material selection and inadequate biocompatibility analysis is only responsible for 0.5% of the failures?  You can't make this stuff up.

[WakeUpTime]

Lawsuits are also being initiated in the Netherlands from hospitals to recover their costs with administering the Recall, costs to correct faulty devices, and the 'health damage to patients'.

“Hospital recovers damage caused by devices from Philips”
https://taketonews.com/hospital-recovers...m-philips/
June 29, 2022

The UMC Utrecht (Netherlands) has held electronics company Philips liable for “all damage and costs” that the hospital and its patients suffer as a result of problems with the company’s sleep apnea and respiratory equipment. Three other university hospitals, in Rotterdam, Groningen and Maastricht, are also considering holding the company liable. 

Also read the background story: Philips helps Jula breathe, but what is she getting into her lungs?

According to the American health care regulator FDA, this concerns 15 million devices worldwide. Philips expects to have to replace or repair 5.5 million devices. It is no coincidence that these four teaching hospitals are announcing or considering legal action. They house a Center for Home Respiration (CTB) where patients with serious lung and muscle diseases are treated. The staff helps them set up the ventilators and learn how to use them at home. The patients are vulnerable and partially or completely dependent on the devices for their ventilation. The CTB in Utrecht is the largest. In total, the centers use about 2,500 Philips devices that fall under the so-called ‘recall’.

There is a lack of advice from Philips to avoid possible health risks for patients, the manager of the heart and lung department writes on behalf of the hospital, despite the hospital having requested this several times. “This is unacceptable for UMC Utrecht.” The lack of ‘information, advice and instructions’ hinders the hospital ‘seriously in carrying out its duty of care for this vulnerable patient group’.

Philips does not want to respond substantively to the liability claim by UMC Utrecht.  The damage for which the hospital holds Philips liable focuses on, among other things, the working hours for processing and following up on the safety report, costs for corrective measures and ‘health damage to patients’. No amounts are mentioned in the letter. In the other three university hospitals, concrete discussions are currently being held with and between medical departments, lawyers and administrators, several sources report. The hospitals are considering legal action.

[WakeUpTime]

Philips now indicates that fixes and replacements now to increase into 2023 from its earlier goal of 2022.

"As Philips works to replace or repair recalled devices, supply problems are slowing it down"
Patients won’t know when they will get a replacement sleep apnea device until “at best a few weeks before it is delivered”
June 30, 2022
https://www.medtechdive.com/news/philips...es/626369/

Philips had produced 2.7 million replacement devices and repair kits, and shipped 1.1 million. [...] The chip shortages and other supply chain problems forced Philips to push back the date for when the repair and replacement program will be completed to 2023.

Also referenced within the article:  
"Philips commits more cash to recall as U.S. Department of Justice issues subpoena"
https://www.medtechdive.com/news/philips...ts/622599/

[btreger]

From Last Week:


Philips Respironics Released an Update On PE-PUR Testing Results and Conclusions Available to Date


WakeUpTime and I provided a number of posts with this information and our own interpretation of the information in this release.

Nicko Dundai of "CPAP Reviews" has provided his own take on this Philips update on YouTube at:

Philips Foam Testing Results Exposed - 124 Dead - YouTube

[WakeUpTime]

<< above 'Foam Test Results' video >>

Coming from his industry background and practical experience, his analysis of the Philips report is significant and startling indeed.  He can uniquely sniff through details far more than most ever could.  It's disgusting how Philips has dramatically manipulated its testing to produce favorable results.  

True news reporters wouldn't merely re-publish Philips' Press Release.  They'd provide an analysis of the report.  Fortunate for Philips, almost all news outlets will merely re-distribute Philips' official Press Release without question, therefore providing Philips corporate with a substantial amount of defensive worldwide marketing and minimal cost.  Philips has put a substantial amount of legal and marketing resources behind this most recent Philips Press Release.

I'd challenge everyone to watch the video and make a comment in the comments section of any local news media article that merely re-published the Philips Press Release as a news story.  That will help to educate the general public and news media of the reality of the Recall and how it truly may affect former and current Recalled device users.

I only wish he made the video in a more professional environment.  For those who don't know his background, it will take away from his previously well-earned credibility.
____________________________________________________________________________

For those who may not wish to view the video, here's a summary of some of his response to Philips' internal testing (paraphrasing):

Philips Internal Visual Foam Inspections on Philips Pre-Selected Devices:
- relies on its own visual eyesight inspections 
- doesn't report on the age of devices
- doesn't report on the climate conditions (significant differences in cool & dry vs. hot & humid)

Ozone-cleaning impact:
- visually, Philips states only 7% of devices showed significant foam degradation 
- yet in 2015, Philips knew of the problem and was already replacing the problematic foam in Philips Trilogy Ventilators
- yet in 2018, Philips' own engineering reports with suppliers stated they knew of the problem

Volatile Organic Compound Emissions:
- an earlier report showed Philips foam “failed” emissions testing, yet after lawsuits announced and millions/billions are at stake, Philips more-recent report showed they “passed”

Testing Inhaled Particles:
- Philips internal testing opinion that foam degradation was insignificant was significantly biased as they chose NOT to rely on external independent labs for testing.
- Testing was done with extremely LOW AIR PRESSURES (< 4 cmH20, or 75 L/m) -- completely unrealistic as typical pressures of 10/15/20 cmH2O will produce dramatically different results

Toxicity:
The potentially damaging toxic compounds used in Philips’ foam is unquestionable, as previous scientific studies exist that point to the dangers of these compounds within the body.

Silicone Foam Analysis:
- Philips claims 'passing' yet the existence of an earlier report that the FDA found showing Philips' new foam contains problematic compounds.  The FDA has requested that the new foam undergo new independent lab results.  Since Philips is in-charge of who and how the testing is done, it’s likely that Philips will not surprisingly ‘pass’ their future testing of the new foam.

[btreger]

RE  > above <

Extremely well-done post WakeUpTime. I think you managed to cover all the main points of the video. Which covered the main points of the Philips new update release.

I sent the video link to Dr. Jeff Shuren, who heads the FDA's recall response efforts. I asked for any comments he may wish to share concerning the video and Philips update document.

We shall wait and see.....

[WakeUpTime]

If there was a significant lawsuit against someone, and we allowed them alone to be in-charge of the scientific analysis of all the evidence against them, one woud expect only one evidentiary conclusion.  Its self-preservation.  Quite simply, for Philips, it doesn't get any better.  The Philips CEO (Frans van Houten) would be dismissed if he didn't 'stack the deck' in favor of preserving the Philips stock price and his job I suppose.  It's my hope that more people understand that upon viewing every Philips Press Release and executive marketing video.
 
If not for Nicko Dundai, and a few other well-qualified individuals, no one would be available to challenge Philips' claims.  The media isn't qualified to pour through the details stated within Philips' 'scientific studies'.  The news media minimally understands CPAP technologies.  The media can’t get unbiased opinions from DMEs, who continually fear jeopardizing their current and future relationship with Philips along with the wrath of Philips legal department, though they'll be quite busy for a few more years.  Patients can’t do it on their own, and consumer protections are minimal (notwithstanding those in Australia and New Zealand).

[btreger]

Reply from the FDA

Last evening I sent out an e-mail to Dr. Jeff Shuren as stated above. This morning I received his response. This is a summary of that e-mail response.

He appreciated that I had taken the time to e-mail him. He apologized for not being able to directly respond to it. He explained that because they are in the midst of investigative and enforcement matters involving the company. These communications could become part of future legal proceedings.

[sawinglogz]

The FDA already has some pretty sharp people who will be combing through the data themselves, but it never hurts to point them in the right direction. They were already pretty unimpressed with Respironics' processes after their inspection.

[TimaaaaaaaahRocks]

The FDA already has some pretty sharp people who will be combing through the data themselves, but it never hurts to point them in the right direction. They were already pretty unimpressed with Respironics' processes after their inspection.

FDA may have some sharp people, but you can't say they are effective at safeguarding public health and welfare from crooked corporations. The FDA has not used any available enforcement actions to punish philips for their crimes or deter other corporations from selling dangerous, misbranded, garbage to patients in need. Selling a misbranded medical device and not following federal law concerning quality systems is a crime. Philips-Respironics obviously manufactured, marketed and delivered millions of misbranded medical devices.....for years. One year plus since public disclosure of a problem they knew about for years - and they have yet to resolve the problem for a majority of their customers.  

What has the FDA done besides write a few lapdog letters and conduct a few wayyyyyy overdue inspections? Nothing. Start fining philips on a daily basis for every illegal device left on the market and see how quickly units get replaced. As it stands, they have no motivation to resolve the recalled devices. In fact just the opposite is true - the longer they drag their feet the more likely effected patients will replace their cpap on their own, or just die waiting. 

The FDA has some real tools at their disposal, so why keep writing letters that the folks on murry ridge use as toilet paper?


CHAPTER III - PROHIBITED ACTS AND PENALTIES

PROHIBITED ACTS

SEC. 301. [331] The following acts and the causing thereof are hereby prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
© The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404 or 505.
(e) The refusal to permit access to or copying of any record as required by section 412 or 703; or the failure to establish or maintain any record, or make any report, required under section 412, 505(i) or (k), 512(a)(4)©, 512(j), (l), or (m), 515(f), or 519, or the refusal to permit access to or verification or copying of any such required record.
....
(g) The manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.
.....

PENALTIES

SEC. 303. [333] (a)(1) Any person who violates a provision of section 301 shall be imprisoned for not more than one year or fined not more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1) of this section², if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both.