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

[ST Dog]

As I said, "All the known facts to this point are already in previous posts"

They didn't go from denying everything to "potential" recently, as youh= implied.

They said potential from the start of this, nearly 2 years ago (not 2.5, the first word was late April 2021).

[TimaaaaaaaahRocks]

They didn't go from denying everything to "potential" recently, as youh= implied.

They said potential from the start of this, nearly 2 years ago (not 2.5, the first word was late April 2021).

No harm or low risk of harm are kind of moot points. Would love to see respironics defend that crap in court. 

Attorney to MD expert witness: "is huffing or receiving pressurized foam particles of any type into a human's lung harmful? If so what amount could be considered hazardous?"

MD expert witness to attorney: "yes, duh, any amount, duh"

[btreger]

SOKOLOVE LAW


Latest Philips CPAP Recall Updates to Know About in 2023

In February 2023, the United States Food and Drug Administration (FDA) announced a recall of reworked Philips Respironics machines due to silicone foam deterioration that, if inhaled, could cause serious illness, injury, and even death.

The FDA categorized the updated recall as a Class 1 recall — the most severe classification of FDA recalls — and follows nearly two years of the healthcare equipment manufacturer coming under various recalls and public scrutiny.

The updated recall applies to more than 13,000 machines, including Philips Trilogy 100®, Trilogy 200®, and Garbin Plus® models distributed between March and September 2022.

As of March 10, 2023, no deaths have been reported in connection to the faulty machines. However, more than 80 reports of the machine’s silicone foam deteriorating have been received, with 19 people saying injuries from the foam.

After a 3-month inspection, the FDA found executives knew of the foam-degradation problem for well over a year before issuing a voluntary recall. Warnings from inside the company dating back to 2016 included “at least 14 tests” showing the company was “aware of issues and concerns related to the potential foam degradation.”

Latest Philips CPAP Recall Updates in March 2023 | Sokolove Law

[btreger]

AboutLawsuits.com

Philips CPAP Health Issues Continue To Surface Long After DreamStation Recall

Nearly 100,000 reports have been received involving health problems from Philips CPAP machines recalled less than two years ago

Between April 2021 and December 31, 2022, the FDA now indicates that it has identified more than 98,000 problems reported to the agency, including at least 346 deaths. This represents an increase of more than 30% for deaths linked to the Philips CPAP machines during November and December 2022, and the number is likely to continue to grow in the future.

The health problems reported have ranged from incidents of Philips CPAP causing cancer to individuals diagnosed with severe lung damage and long-term respiratory side effects, such as chronic obstructive pulmonary disease (COPD), reactive airway disease (RAD), acute respiratory distress syndrome (ARDS), sarcoidosis, pneumonia, asthma, and other issues.

Are there long-term side effects for Philips CPAP users?

Yes. Prolonged exposure to chemicals and particles released as the CPAP sound abatement foam deteriorates may cause users to develop long-term health risks, including cancer of the organs, liver and kidney disease, and respiratory diseases.

Warnings released by the FDA following the CPAP recall have specifically warned that inhaling the deteriorating black foam particles and chemicals released into the device’s air tubes can cause long-term problems such as:

Inflammatory responses cause internal scarring and damage to tissues and organs
Toxic or cancer-causing effects on organs, such as kidneys and liver

Claims that the foam and gasses released by the machines have caused them to develop;

Bladder, Lung, Kidney, Liver, Colon, and Other Cancers
Pulmonary Fibrosis, Interstitial Lung Disease, Sarcoidosis, and Other Lung Damage
Liver Disease, Kidney Disease, Heart Attack, Heart Failure, or Stroke

Philips CPAP Health Issues Continue To Surface Long After DreamStation Recall - AboutLawsuits.com

[anonEmouse2004]

I commented previously on having received my replacement. Today I received the below email informing me that I must register my replacement machine with my DME. What difference does it make?

"We are pleased to inform you that our records show your Philips Respironics replacement device has shipped.
Your device is set to factory default settings.  To update your device to your prescription settings, you must contact your physician. To maintain ongoing care, resupply of accessories and any warranty needs you may have, you must contact your Durable Medical Equipment Provider (DME) to inform them you have received your device and to provide them with your serial number for their patient management system.
If you do not have a DME, contact your prescribing physician or insurance carrier for the names of DME providers in your area. Also available to you is FreedomLink at 877-899-4533, which is a free service offered to patients to help them find providers in their local area or in an area where they may have relocated to. 
Please visit Philips.com/src-update for more information and continued updates, including the latest answers to frequently asked questions (FAQs), or call 833-262-1871.
We appreciate your patience throughout this process.
Thank you."

[Phaleronic]

I commented previously on having received my replacement. Today I received the below email informing me that I must register my replacement machine with my DME. What difference does it make?

"We are pleased to inform you that our records show your Philips Respironics replacement device has shipped.
Your device is set to factory default settings.  To update your device to your prescription settings, you must contact your physician. To maintain ongoing care, resupply of accessories and any warranty needs you may have, you must contact your Durable Medical Equipment Provider (DME) to inform them you have received your device and to provide them with your serial number for their patient management system.
If you do not have a DME, contact your prescribing physician or insurance carrier for the names of DME providers in your area. Also available to you is FreedomLink at 877-899-4533, which is a free service offered to patients to help them find providers in their local area or in an area where they may have relocated to. 
Please visit Philips.com/src-update for more information and continued updates, including the latest answers to frequently asked questions (FAQs), or call 833-262-1871.
We appreciate your patience throughout this process.
Thank you."

I had the same email for my autobipap, I don't use DMEs so there's nothing I'm going to do but self-titrate.

[btreger]

Lawsuit Information Center


CPAP Lawsuit Settlement and Verdicts

Health Problems Linked to Recalled CPAP Machines

6 months of CPAP Use:

Our initial evidence suggests that 6-month of inhaling the chemical foam particles from a recalled CPAP machine could be linked to increased rates of cancers involving the blood, lymph nodes, mouth, and throat. This would include

Acute Myeloid Leukemia (AML)
Bone Marrow Cancer
Esophageal Cancer
Hematopoietic Cancer
Laryngeal Cancer
Leukemia
Lymphoma
Multiple Myeloma
Nasal Cancer
Non-Hodgkin’s Lymphoma
Soft Palate Cancer
Sinus Cancer
Throat Cancer
Tonsil Cancer

2 Years of CPAP Use:

Using a recalled CPAP machine for a period of 2-years or longer could be linked to cancers involving the thyroid or related organs. This includes both thyroid cancer and papillary cancer.

5 Years of CPAP Use:

Using a recalled CPAP machine for 5 years or longer can potentially be linked to cancers involving the major organs. Specific cancer types in this causation category include

Bladder Cancer
Brain Cancer
Colon Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Rectal Cancer
Skin Cancer
Stomach Cancer
Testicular Cancer

The long-term consequences of polyester-based polyurethane (PE-PUR) foam are not something that has received a great deal of research.  So the science on the harms CPAP can cause will evolve.  There will be many patients to evaluate.

Over 15 million!   DreamStation, CPAP, and BiPAP machines sold from 2009-2021 have been recalled.

What Is the Average CPAP Settlement Amount Your Lawyers Expect?

Based on these comparisons, our lawyers believe the likely settlement payout for Philips CPAP claims will be as follows:

Settlement Tier                                             Estimated Settlement

Tier I                                                               $150,000 – $250,000

Tier II                                                              $75,000 – $150,000

Tier III                                                             $10,000 – $75,000

CPAP Settlements and Verdicts

2020, South Carolina: $485,000 Settlement

2018, Louisiana: $300,000 Verdict

2016, Ohio: $1,200,000 Settlement

2012, Alabama: $15,000,000 Verdict

2011, Massachusetts: $1,200,000 Settlement

CPAP Machine Lawsuit Settlements and Verdicts | January 2023 (lawsuit-information-center.com)

[convoluter]

I registered my recalled System One Auto CPAP over a year ago, and a replacement arrived yesterday. It was a refurbished Dreamstation 1 Auto CPAP. Having a refurbished machine is ok with me because I had been keeping the System One for backup only and that's the purpose I'm hoping the Dreamstation will serve. I currently use a Resmed 10 Auto CPAP.  

Unfortunately, the System One replacement was *only* the Dreamstation.  There was no power cord, no humidifier, no heated hose, etc. If Philips were replacing a Dreamstation, this might make sense, but none of these things from the System One work with the Dreamstation, not even the power supply (it says "check power" when I plug it in, even though it is an 80W power supply, as I understand the Dreamstation requires.)

I tried calling Philips on the number they supply in the documentation with the replacement machine, but after I got through the phone tree and waited about 10 min., they just hung up on me. Foolishly thinking this was a fluke, I tried again, with the same result.

I'm not eager to buy the missing parts to make the replacement work, and I don't seem to be able to get through to Philips.  

Surely someone has faced this same issue before...and I'm not in a hurry since the Dreamstation is going to serve as a backup...  Has anyone here encountered (and hopefully solved) this problem?

Thanks for any advice.

[SleeplessinPgh]

I tried calling Philips on the number they supply in the documentation with the replacement machine, but after I got through the phone tree and waited about 10 min., they just hung up on me . . . Surely someone has faced this same issue before...and I'm not in a hurry since the Dreamstation is going to serve as a backup...  Has anyone here encountered (and hopefully solved) this problem?

I don't know which number you called, but I had success calling the Philips Recall Support Team at 833-262-1871.  I called early (8:00 - 8:30 am Eastern Time) on a weekday and got through fairly quickly.  Good luck getting this resolved.

[convoluter]

Thank you, SleeplessinPgh... I called them around the same time you did, and got through directly to a person. They were helpful and after they took some serial numbers they told me the missing parts would be shipped to me.  

Hopefully this will solve the problem. Guess it matters what time of day you call!