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

[ejbpesca]

I recieved a letter recently that I could be reimbursed $100 due to my owning a defective SYSTEM ONE CPAP machine.  I did not pay for it, Medicare did, so no application will be made for the money.

[KSMatthew]

I recieved a letter recently that I could be reimbursed $100 due to my owning a defective SYSTEM ONE CPAP machine.  I did not pay for it, Medicare did, so no application will be made for the money.

That $100 is apparently reimbursement for your trouble for sending back the recalled unit.  I'll need to look more closely at the letter, but I thought it was an automatic reimbursement - if they have a record of your returning the CPAP, you'll get that money unless you opt out.

[btreger]

FDA

ResMed

ISSUE: ResMed is updating its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require a return of a mask with magnets unless the patient is contraindicated.

ResMed masks with magnets were distributed nationwide and globally from 2014 to November 2023. The impacted Mask with Magnet product(s) can be identified by the model number: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i on the cushion or frame of the masks.

ResMed has submitted five reports of serious harm (medical intervention/hospitalization) that were potentially related to magnetic interference of a mask with a magnet with an implanted device to relevant regulatory authorities.

FDA MedWatch - Updated Instructions and Labeling for Masks with Magnets by ResMed (govdelivery.com)

[btreger]

PROPUBLICA

“With Every Breath” Captures the Human Toll of Philips’ Failure to Disclose Dangerous Defects of Its CPAP Devices

A new short documentary from ProPublica and the Pittsburgh Post-Gazette follows patients and a doctor navigating the fallout of the massive recall of Philips breathing machines.

ProPublica Documentary: The Human Toll of Philips CPAP Recall — ProPublica

[ejbpesca]

That $100 is apparently reimbursement for your trouble for sending back the recalled unit.  I'll need to look more closely at the letter, but I thought it was an automatic reimbursement - if they have a record of your returning the CPAP, you'll get that money unless you opt out.

I don't have the letter but I do recall reading the $100 was available if I paid for the device, which I did not.  Yet, maybe I got that wrong.

[btreger]

FDA

Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas

Reason for Recall
  
Philips North America LLC is recalling the Panorama 1.0T HFO due to the risk of explosion during a quench procedure caused by excessive pressure buildup of helium gas.

During a quench, which is not common, a large amount of helium evaporates and is vented outside the building through a venting system. If an unknown blockage is present in the venting system and the pressure exceeds design limits, the system's structural integrity could be compromised. The magnet in the Panorama 1.0T HFO may experience an unintended quench during normal use or when initiated in an emergency by the operator pressing the Magnet EMERGENCY STOP button.

The use of an affected system may cause serious adverse health consequences, including chemical exposure, lack of oxygen, tissue damage, and mechanical trauma caused by debris, such as brain injury, laceration, fracture, eye injury, bruises, and death. The issue could also lead to system or property damage. 

There has been one reported event of an explosion in 22 years of use. There have been no reports of injury or death.

Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas | FDA

[WakeUpTime]

“With Every Breath” Captures the Human Toll of Philips’ Failure to Disclose Dangerous Defects of Its CPAP Devices
ProPublica Documentary: The Human Toll of Philips CPAP Recall — ProPublica

That 20-minute video news summary should be watched by everyone affected by the Recall.  It's a good overview of the 2+ year journey that most of us have gone through - and are still going through as a result of lingering concerns of either known, or yet known, side effects as a result of the lengthy use of Philips' faulty foam.

I found it rather difficult to watch.  Many sleep apnea patients already have significant challenges in life, with the effects of an often-delayed diagnosis, their daily & nightly CPAP routine, and other medical issues either related or unrelated to use of their CPAP.

Patients, doctors, sleep therapists, and equipment providers had far too much trust with one of the world's largest medical equipment providers.  Many diagnosed sleep apnea patients are as vulnerable as 10 year-olds walking into car dealerships to buy a car.

My biggest takeaway from the Recall is that patients should always keep in mind:

• "Recommenders" are often incentivized or inappropriately influenced for their biased opinions
  
• "Recommenders" often blindly put their full trust in the text and actions of equipment makers
  
• Many equipment makers have one primary interest (next quarter's profit and stock price)
  

Thank goodness for ApneaBoard and the ongoing contributions by ApneaBoard Members.

[btreger]

While waiting for my family to arrive, I sat down at my computer, and am very sorry to have found this today  

PHILIPS 

Explained: Silicone sound abatement foam used in DreamStation 2 and the sleep and respiratory care devices remediated as part of the June 2021 Philips Respironics recall




The silicone sound abatement foam used by Philips Respironics in the replacement devices has been shown in some tests to emit chemicals, including formaldehyde. Can you explain this?


The levels of formaldehyde detected in all devices that contain silicone sound abatement foam were well below the formaldehyde limit established by the World Health Organization, a global public health authority. Additionally, the levels detected were even further below the more recent formaldehyde limit established in 2023 by the FDA and other medical authorities.


In this respect, it is important to distinguish between a hazard, which is something that – at certain levels – has the potential to cause harm, and risk, which is the likelihood that a hazard will cause harm. For example, acetone is a common chemical in plastics, specifically in nail polish remover. Hazards associated with acetone include skin irritation, dizziness, etc., but acetone is not a risk under normal exposures. Similarly, formaldehyde is omnipresent in daily life. It is present in the human body, certain foods (e.g., pears, cauliflower), cardboard, carpeting, etc. Formaldehyde can be a hazard, but it is not considered a risk when the exposure levels are below the applicable regulatory limits.

NOTE: After all the pain and suffering Philips has caused so many thousands of people, it is still hard to believe that they are still capable of putting out this level of crap. 

Explainer on foam used in DreamStation 2 and other devices | Philips 



 

[btreger]

YouTube.com

How to Claim Money From Philips Class Action Settlement In 3 Minutes

By Nicko Dundai

Claim Up To $1500 From Philips Cpap Lawsuit In 3 Minutes (youtube.com)

[KSMatthew]

Has anyone sent back their replacement CPAP yet?


I’m one of those people that bought a Resmed right after the recall. Then I got a replacement DreamStation 2 and returned my original, recalled, DS 1. I haven’t returned the DS 2 yet and was wondering if anyone else done it.