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

[TwoSleepy]

In response to the question about Hotmail, my "Update on your Philips registration" with my registration number went to my Hotmail Junk folder.

I have gone back to using my old Resmed 9 machine, and managed to obtain an Airsense 10 to replace my wife's Dreamstation.

[Sea Papper]

@Sea Papper,  Listen - There is nothing wrong with being upset at this situation. We are ALL upset.

The FACT is, YOUR comment suggesting Philips is criminally conspiring by "design" to cause email deliverability issues is about as wrong as wrong can get.

OK fair, lets just agree, maybe, that any organization sending emails with "noreply" in the address don't know jack squat about how ISPs and mail servers filter spam. Mailchimp would absolutely do a better job. 

It is apparent that employees at Philips/Respironics criminally conspired for 12 years or so to ship products that we're illegally labelled as medical devices. An accurate bio-compatibility analysis is a legal requirement.....The whole QA process for dealing with and reporting defects is a legal requirement. Is it a giant leap to conclude that they aren't exactly concerned with timely and accurate communications concerning a Class 1 recall? 

So what if they don't sell directly to customers. Respironics is the irresponsible party here, not the DMEs who have to incur the expense and inconvenience of mopping up their mess, and certainly not the millions of patients whose health has been compromised on two fronts: huffing poison for who knows how long, and now being told to turn the machine off and wait up to 12 months for a replacement. The cop out that the FDA is currently holding up shipment of replacement units is beyond inexcusable. They had years to correct the problems and obtain regulatory approval. Instead, they waited until they had a new product launch. FDA best be giving a thorough review of that shitbox. 

Just wait and see what gets uncovered during the tidal wave of lawsuits. Soon enough, some state attorney general will open a criminal investigation into who knew what, when, and where, and drag the FDA to the table. What have they done in this matter that any reasonable court wouldn't find to be a criminal act when held up against Code of Federal Regulations Title 21 CFR? Respironics has handled this FoamGate issue about as wrong as wrong can get.

[Sea Papper]

Sea Papper
just what is your stake in this game? per your profile, you have no machine, no mask, no pressure and you are not using software, so what exactly is your interest?

Plaintiff in a soon to be filed lawsuit.

[btreger]

A short time ago I posted an e-mail I had just received from Medicare. There has been no response, and I would think this particular sentence would have had some impact, or maybe not.

If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than 5 years old. 

[btreger]

There have been ongoing posts concerning receiving or not receiving the Philips e-mail.

I have not read anybody discussing what was said in the e-mail:

"Currently, we are processing the device serial number registrations that have been received'

I registered my device in mid-June, which means for a least 2 months Philips has been doing nothing with registered users until now.

You would think that they would be processing registrations as soon as they got them, which would be the most efficient way to process a very large number of growing registrations.

I personally think this was just a PR stunt, probably recommended by their lawyers, so they can now say they have been in communications with their users. 

Remember in all the lawsuits and print media we have posted and discussed here, everyone was saying the same thing, no communications,
no news or information from Philips.

[Gideon]

What is not mentioned is timeframe. PR has stated it is a one year process.
If your doctor determines that you cannot wait you may be able to justify an earlier replacement especially if you can prove foam deterioration via black flecks in mask or AB filter.

[mrmagloo]

OK fair, lets just agree, maybe, that any organization sending emails with "noreply" in the address don't know jack squat about how ISPs and mail servers filter spam. Mailchimp would absolutely do a better job. 

It is apparent that employees at Philips/Respironics criminally conspired for 12 years or so to ship products that we're illegally labelled as medical devices. An accurate bio-compatibility analysis is a legal requirement.....The whole QA process for dealing with and reporting defects is a legal requirement. Is it a giant leap to conclude that they aren't exactly concerned with timely and accurate communications concerning a Class 1 recall? 

So what if they don't sell directly to customers. Respironics is the irresponsible party here, not the DMEs who have to incur the expense and inconvenience of mopping up their mess, and certainly not the millions of patients whose health has been compromised on two fronts: huffing poison for who knows how long, and now being told to turn the machine off and wait up to 12 months for a replacement. The cop out that the FDA is currently holding up shipment of replacement units is beyond inexcusable. They had years to correct the problems and obtain regulatory approval. Instead, they waited until they had a new product launch. FDA best be giving a thorough review of that shitbox. 

Just wait and see what gets uncovered during the tidal wave of lawsuits. Soon enough, some state attorney general will open a criminal investigation into who knew what, when, and where, and drag the FDA to the table. What have they done in this matter that any reasonable court wouldn't find to be a criminal act when held up against Code of Federal Regulations Title 21 CFR? Respironics has handled this FoamGate issue about as wrong as wrong can get.

I'll let the moderators deal with your nonsense. Nobody here has ever excused Philips, and this situation is definitely tough, but making up lies and crazy notions doesn't help the cause here.  Done with you.  Good luck with your agenda.

[WakeUpTime]

For recalled device users in Australia, which has strong consumer protection laws, you may wish to visit the link below.  The Australian Government is referencing two forms of protections specifically regarding the Philips Recall - seeking a refund from Philips via what appears to be Australia's version of the U.S. FDA, and/or assistance via Australia's Consumer Protection Law.

Australian Government
Department of Health
Therapeutic Goods Administration

"Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators"
https://www.tga.gov.au/alert/philips-rec...entilators

You may be entitled to a refund or reimbursement for your Philips recalled device.

Philips is responding to consumer requests for refunds. If you are not satisfied with the refund or reimbursement offered, you should request the offer be reviewed. You can do this via the Philips Electronics Australia Ltd support hotline.

In addition, you have rights under the Australian Consumer Law which are entirely separate to any remedy Philips may provide as part of this recall action.

[btreger]

For recalled device users in Australia, which has strong consumer protection laws, you may wish to visit the link below.  The Australian Government is referencing two forms of protections specifically regarding the Philips Recall - seeking a refund from Philips via what appears to be Australia's version of the U.S. FDA, and/or assistance via Australia's Consumer Protection Law.

Great post, but also a little depressing. We can now compare the differences in consumer protection laws.

[Mustang 85]

Regarding Post # 1286:

The civil tort system in the US is not and never has been a fact finding operation. It is an adversarial system where one side tries to out-argue the other and the side with the best argument, or the best arguers, wins. 

What is claimed by a plaintiff attorney in a lawsuit is not “fact”, but rather is “accusation”. The only way to determine if in fact that Philips knew for years a out the foam problem is to produce documentation in Philips possession demonstrating that knowledge via discovery through litigation, which has not happened yet, and may not happen if such documentation does not exist. 

So we shouldn’t be calling something fact when it is accusation, and we shouldn’t be calling people criminals until they have been adjudicated in court.  Philips behavior is inexcusable, and may very well be unethical, but a lot of unethical behavior is not held to be criminal under the law.