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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-17-2022
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF PENNSYLVANIA
IN RE: PHILIPS RECALLED CPAP,
BI-LEVEL PAP, AND MECHANICAL
VENTILATOR PRODUCTS
LITIGATION,
This Document Relates to All Action
Master Docket: Misc. No. 21-1230
MDL No. 3014
AMENDED INTERIM PRESERVATION ORDER
(APPLICABLE TO TRILOGY DEVICES)
WHEREAS, Philips RS has submitted to the FDA a proposal for rework and remediation
of Trilogy Devices, as defined below, under which Trilogy Device users will have the PE-PUR
foam, and if necessary the airpath components, of the Trilogy Devices, removed and replaced, and
the user’s same Trilogy Device will then be returned to the user, and the FDA has allowed rework
and remediation activities to proceed; and
WHEREAS, Philips’ RS represents that new Trilogy Devices are not being manufactured,
and the number of available Trilogy Devices makes it infeasible for Philips RS to preserve whole
Trilogy Devices without interfering with the FDA-allowed rework and remediation plan or to
allow Trilogy Device users to preserve their own Trilogy Device and also receive a replacement
Trilogy Device.
3014_Amended_Interim_Preservation_Order.pdf (uscourts.gov)
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-21-2022
Reuters
Philips says tests on recalled products show limited health risks
AMSTERDAM, Dec 21 (Reuters) - Dutch health technology company Philips (PHG.AS) said on Wednesday independent tests on its respiratory devices involved in a major global recall had shown limited health risks.
Philips said the latest tests indicated that exposure to particulate matter emissions from degraded foam in DreamStation devices was "unlikely to result in an appreciable harm to health in patients", provided the machines had not been treated with ozone-based cleansing products.
Philips says tests on recalled products show limited health risks | Reuters
More info on this can be found at FIERCE Biotech
https://www.fiercebiotech.com/medtech/philips-testing-finds-minimal-risk-patient-harm-some-recalled-cpap-and-bipap-machines
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-23-2022
FDA
Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris: FDA Safety Communication
Date Issued: December 22, 2022
The U.S. Food and Drug Administration (FDA) is providing additional information to patients, caregivers, and healthcare providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 200 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The two recent issues are:
The silicone sound abatement foam, installed to replace the PE-PUR foam, may separate from the plastic backing due to adhesive failure. The silicone foam material may potentially move and block the airpath, which may reduce airflow in the ventilator and could also cause the device to alarm. If an alarm is not recognized or acted upon, the patient could experience trouble breathing, such as asphyxia, hypoventilation, or hypoxemia, which can be life-threatening. BiPAP and CPAP machines reworked or replaced due to the recall in June 2021 are not affected by this silicone foam adhesion failure. The adhesive is not used to hold the silicone foam in place in the reworked or replaced BiPAP and CPAP machines.
Additionally, Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Further exposure to PE-PUR foam may cause potential health risks, which can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Preliminary results show PE-PUR and environmental debris in some samples.
Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris: FDA Safety Communication | FDA
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - ST Dog - 12-23-2022
(12-23-2022, 10:08 AM)btreger Wrote: The silicone sound abatement foam, installed to replace the PE-PUR foam, may separate from the plastic backing due to adhesive failure.
did they have problems with the foam adhesive on these machines previously?
I realize adhesives that are safe to use in the airpath are difficult to find/develop, but I am surprised to see this again.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - JJJ - 12-23-2022
I received my replacement DS1 BiPAP as couple months ago (reported in this thread), and the replacement was in a double box, where the inner box was to be used for returning the old one, with an included free shipping label. My reaction was 'when hell freezes over,' and the old one resides on a shelf in a closet, where it's going to stay.
Today I got the following e-mail from Phillips:
Code:
From: Philips <globalintake-noreply@sedgwick.com>
To: "johnjasonj@gmail.com" <johnjasonj@gmail.com>
Subject: Reminder to return your original Philips Respironics device
Date: Fri, 23 Dec 2022 11:01:19 -0800 (PST)
Reply-To: Philips <globalintake-noreply@sedgwick.com>
We appreciate your patience throughout the process of replacing your Philips Respironics device.
According to our records, you should have received your remediated replacement device. If you have not received your replacement yet or have questions about returning your device, please contact us at 1-833-262-1871.
If you have received your replacement device, please remember to return your original affected device to Philips Respironics. Patients who have received a replacement device have the option to return their original affected device at no charge back to Philips Respironics. The affected device will be remediated, cleaned, and disinfected so it can be provided to another patient who is waiting on a replacement. Returning your affected device to Philips Respironics is an important part of our remediation process. For instructions on how to return your original device or additional support, please visit our website here
https://www.usa.philips.com/healthcare/e/sleep/communications/src-update/news/how-to-return-your-affected-device
or call 1-833-262-1871.
--------------------------------------------------------------------------------
Our service providers are bound by the same high standards of data protection that we as Philips adhere to. We would like to emphasize that at Philips we have the highest regard for your privacy. View our privacy policy
https://www.usa.philips.com/a-w/privacy-notice.html?elqTrack=true&origin=3_us_en_b2bbgusestoreupdatetiereduser__b2b_aug_link16339973252_email68243_&utm_source=eloqua&utm_medium=email&utm_campaign=b2bbgusestoreupdatetiereduser&utm_content=email68243
Copyright © 2021 Philips Respironics, All rights reserved.
Our address is:
Amstelplein 2, 1096 BC, Amsterdam, Netherlands
If you do not wish to receive future email , click here
https://a44529.actonservice.com/acton/rif/44529/s-004d-2212/-/l-00a4:64b8b/q-00c1/zout?sid=TV2%3Asn6mWF8eRThey have no way to enforce their request, so I will ignore it.
.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SuperSleeper - 12-23-2022
(12-23-2022, 05:16 PM)JJJ Wrote: They have no way to enforce their request, so I will ignore it.
.
As will I, if and when my machine is ever replaced.
Basically, returning the machine will reduce THEIR remediation costs, plus it will cause yet another patient to get a refurbished DS1 instead of a brand new DS2. Returning the machine has no benefit to ANY patient. All the benefit goes to Philips.
Seeing as they knew about this whole issue and chose not to do anything about it for months and months, I don't feel as though we owe them anything.
Therefore... I will not comply.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - StratCat48 - 12-23-2022
JJJ.....
"I received my replacement DS1 BiPAP as couple months ago (reported in this thread), and the replacement was in a double box, where the inner box was to be used for returning the old one, with an included free shipping label. My reaction was 'when hell freezes over,' and the old one resides on a shelf in a closet, where it's going to stay.
They have no way to enforce their request, so I will ignore it."
While I totally get where you're coming from (P*ssed at Philips) and I was going to keep my recalled DS1 originally as well, there are folks out there that can not afford to buy a replacement CPAP out of pocket. Holding onto one that serves no purpose to you other than take up closet space only lengthens the time for someone to receive their replacement and continue therapy. I as well was pretty PO'd at Philips, but after giving it thought, I didn't want to screw someone else waiting by no fault of theirs that could use a machine and I did finally ship the DS1 back.
Somewhere many months ago in this board or the other CPAP board, someone posted about Philips could possibly bill for unreturned machines and this was kinda/sorta a statement buried in the registration process that was agreed to for the replacement. I went back in what I had copied/downloaded during registration and could find nothing. If indeed there was something stating such, Philips could possibly have a leg to stand on if they wanted to and bill for an unreturned machine. Not sure how far it would get if they tried.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - StratCat48 - 12-23-2022
"SuperSleeper....
Basically, returning the machine will reduce THEIR remediation costs, plus it will cause yet another patient to get a refurbished DS1 instead of a brand new DS2. Returning the machine has no benefit to ANY patient. All the benefit goes to Philips."
JJJ's machine is a BiPAP, thus can not get replaced with a DS2. It would only speed up the process for someone to get a DS1 BiPAP even if refurbished.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Gideon - 12-23-2022
Supersleeper I believe you have a mistake n your above post.
You stated they knew about it for "months and months", I believe that should read years and years.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - SuperSleeper - 12-23-2022
(12-23-2022, 08:18 PM)Gideon Wrote: You stated they knew about it for "months and months", I believe that should read years and years.
Yep, you're right- my mistake. Years and years. Thanks for correcting that.
and a big sarcastic THANKS to Philips... sure appreciate what your company does for us.
I probably am gonna get lung cancer from the year or so I used my DreamStation machine. Could have even contributed to my current lung issues, but there's no way to prove it, of course.Sure, I'll send your precious machine back to you. Right after you pay for ALL my medical bills and give my wife a large settlement for when I die.
Don't mind sending it back at all, in that case.
You think I want another patient to get one of these "refurbished" machines? You think anyone should ever trust Philips again? After they tried to cover up what happened? Nope, I'm not going to be responsible for them sending one of their death machines to another patient.
And I'm only half kidding about all that. Well, actually not so much.
