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Pacific Daily News

Guam included in CPAP respirator recall:

Guam residents are included in the voluntary recall of CPAP and BiPAP respirator products, according to a news release from the Office of the Attorney General.

Philips Respironics, the company that produced the devices, recently sent a letter to Attorney General Leevin T. Camacho and attorneys general from other territories informing them about the recall plan.

Guam included in CPAP respirator recall | Money | guampdn.com
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(04-10-2022, 03:21 PM)Laslo Wrote: I had two Phillips CPAPS that needed to be replaced.  I got the Dreamstation 1 replaced with the Dreamstation 2, but they still have not replaced my Dreamstation GO. Very annoying.

My Dreamstation GO also awaits their attention.  My guess is that in their scheme of prioritizing repairs, machines marketed for travel purposes are at the bottom of the list because they have concluded that those buyers have another machine that they are able to use in the meantime.
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Media News Update
"Philips Respironics CPAP Recall Leaves Many Patients With Difficult Choice"
CBS News Boston | April 8, 2022

Quote:Philips Respironics does not own or manage the CPAP patient’s contact information – many patients purchase their devices through third parties. Philips Respironics is working with those third parties (Durable Medical Equipment providers – DMEs) to also reach patients directly as quickly as possible. We are working around the clock to continue to reach out to our customers and patients.

This recall / field safety notification affects around 5 million devices worldwide. To address affected devices, Philips has mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with new foam not affected by this issue. The repair and replacement program will be at no cost to consumers.

At this time, Philips is already producing repair kits and replacement devices in large quantities. To date, Philips has produced 1.5 million repair kits and replacement devices, with about 750,000 in the hands of customers. These devices and kits are being sent to patients as they are available. As our production capacity is fully focused on the repair and replacement actions, we are currently not taking orders for sleep therapy devices for new patients.

Regarding estimated timing, we are working to address this issue as expeditiously as possible. We expect to complete the repair and replacement programs in in the fourth quarter of 2022.

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Additional Media Updates - ApneaBoard Referenced
"Alabama Man Believes His Philips CPAP Machine Caused Bladder Cancer"

Quote:The first of the two lawsuits was filed on February 17, 2022, by an Alabama man who says he purchased his Philips’ System One CPAP machine in 2011 for the treatment of his sleep apnea. This is one of the machines included in Philips’ recall. He used it every night for about nine years.  Then in 2020, he experienced bleeding while urinating. Several weeks later, he was diagnosed with bladder cancer and forced to undergo surgery to remove his bladder.  

The plaintiff alleges that his bladder cancer is related to the toxic chemicals off-gassed by his CPAP machine. Philips has disclosed that lab analysis of the degraded foam revealed the presence of harmful chemicals including toluene diamine (TDA), toluene diisocyanate (TDI), and diethylene glycol 20 (DEG).  The U.S. Centers for Disease Control and Prevention (CDC) notes that studies in animals have demonstrated that TDI and TDA are carcinogenic.

"Four Plaintiffs Sue Philips for Failing to Warn Consumers Earlier"

Quote:The plaintiffs argue that Philips knew about the potential risks from its devices related to the degradation of the PE-PUR foam well before notifying the public on June 14, 2021. Consumers complained about black particles in Philips’ devices several years before that, as evidenced by forum posts and statements on internet message boards frequented by obstructive sleep apnea patients.

“Philips, like most companies,” the complaint reads, “monitored message boards, such as apneaboard.com and reddit.com, and social media networks, such as Facebook, and therefore received notice about the potential for PE-PUR foam degradation in the subject devices and black particles in the machines since shortly after launch, if not earlier.”

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The Guardian

Thousands of ventilators were pulled as electrical faults put UK patients’ lives at risk

Two thousand ventilators being used in UK hospitals are at risk of suddenly shutting down due to electrical faults that have led to a global safety alert.

Hospitals have been ordered to source replacement ventilators after Philips Respironics said its breathing support devices could suddenly stop working, in some cases without activating a warning alarm.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the problem related to “a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation”.

Thousands of ventilators pulled as electrical faults put UK patients’ lives at risk | Hospitals | The Guardian
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Buried in that article is the following:
>>> The latest safety alert relates to V60, V60 Plus and V680 Philips ventilators and affects about 105,000 devices globally, and 2,000 in the UK, Philips said.

So I think these are not home-use ventilators.

In addition, the incidence is fairly low:
>>>It said there had been five reported cases of shutdowns in the UK so far, none of which involved patient harm. Globally, there have been 389 reports of failures, including one where the patient died and four where they were seriously injured. In six of the total cases, the warning alarm didn’t sound.

So low probability, but high consequence...
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Philips E-Mail

Like most of you, I received a new e-mail from Philips this morning. Nothing new so I will not post the whole thing. Just the last sentence just shows how stupid Philips thinks we all are, and how out of touch they are with reality. 

"Thank you for your continued patience and trust"
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Regarding the e-mail sent by Tom Wilson to Dr.Jeff Shuren of the FDA

Posted 04/07

This is his response:

Dear Mr. Wilson,

I appreciate you and your fellow patients reaching out to me. I empathize with what people have experienced with the recall. 
We have been engaging with Philips continually to emphasize that they need to manufacture devices that do not have these problems, fix currently available devices in the interim, and provide patients and providers with the information they need.
Our recent legal action ordering the company to provide notification to patients about the recall and the risks of the recalled devices reflects our own frustration with Philips’ activities to date and our efforts to use the tools available to us. We have raised and continue to press on several of the issues and suggestions you raise and will continue to do so.
I appreciate, as well, the desire to have a new, rather than a refurbished device. Given the current state of the manufacturers of these products, there will not be a sufficient number of new devices available in the short term; refurbished devices are the short-term alternative. Some of this is the result of worldwide component shortages about which we have been working with other parts of the US government.

Unless you have concerns, I will share your email with the CEO of Philips, to help him appreciate the breadth and depth of patient concerns.


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(04-15-2022, 02:45 PM)pholynyk Wrote: So low probability, but high consequence...

Yessir. Any failure with "Low probability but with high consequence" should be red flagged by a properly performed risk analysis and never marketed. This isn't just a 'hey the glue dried out and nobody noticed' problem. Just another shoddy design that apparently did not go through proper safety analysis and testing. 

Failure Mode: Adhesive does not hold the capacitor bracket in place.  (adhesive? for real? just a fancy name for glue. they used glue to mount a critical component! I reckon bailing wire, chewing gum, or duct tape were all too expensive.)

Effect: Serious adverse health consequences and death

"If the adhesive fails, it could cause a capacitor support bracket to become loose and potentially damage the capacitors, which could cause the ventilator to stop providing ventilation to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all," the agency wrote.

The effect of the cessation of ventilation on the patient will depend on whether an alarm sounds. In the worst-case scenario, the lack of an alarm could leave the patient deprived of oxygen for "an extended time," FDA said, potentially leading to serious adverse health consequences and death.
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(04-18-2022, 09:18 AM)btreger Wrote: Philips E-Mail

"Thank you for your continued patience and trust"

Every time Philips uses that statement, it invokes frustration and anger.  Getting out in front of bad news and one's deliberate faults by claiming the exact opposite of common belief is indeed a popular tactic used by authoritarian leaders and criminals.  

Is anyone being patient, with complete willingness to continue waiting as long as possible while continually using Philips' faulty medically-necessary products?  Very few.  End-users are waiting, and continuing to use their faulty devices, because they medically and/or economically have no choice but to wait.  

Trust?   It's becoming so common today to get ahead of something bad by insisting the exact opposite.  It promotes the opposite of "trust".  For a company that has already been shown to have deliberately delayed announcing and withholding an immediate "fix" to a known harmful design flaw (short-term or long-term, serious or minor), is at-best disrespectful - and at worst, criminal.  Furthermore, merely beginning a recall compaign is not the same as completely solving a problem.  There are many issues to be delt with (time, costs, damages, reimbursements, corporate neglect, etc.) 

The other tactic of course, in continuing to claim the opposite of a bad deed, is the continued insistence that there isn't (yet) 100% credible evidence to suggest otherwise.  There are many modern day examples.  In essence, very little would be investigated, or invented, if one were required to have pre-existing 100% evidencial proof in all facts to support an definite outcome.  Thank goodness that much can be accomplished after the existence of a significant number of clues and related evidence.

Perhaps the Philips Public Relations Department had no other means to end their correspondence with end-users.  It would be unacceptable to end their e-mails with...

     Best regards,
     The Company that Has Knowingly Deceived End-Users By Continuing to Produce Defective Carcinogenic Products 
     to Continually Enhance Its Profitability and Stock Price
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