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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The DS GO has only a little itty bit of foam in it that can be easily extracted when open. It’s fiddly but not too hard. I had all my 3 philip’s units - DS1, GO, and SystemOne Registered, but I am only exchanging the DS1 for another DS1 (In Aust the DS2 cannot be a replacement since it has not been reg). They only give you the main part of the DS1 but you keep your humifier and all the other bits. I don’t see any point in a new GO as I have already removed the foam and that’s the same for the SystemOne. I guess if I swapped I could get a blower with zero hours but I really haven’t used them enough and I don’t want to go through the hassle of extracting whatever foam they have replaced in the new ones. That said, the DS1 replacement will get operated on to swap blower housing with the foam less one in my current DS1 (which has about 5yrs use). I think this makes sense although maybe I am being lazy.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
My DS1 is 6 years old. No response yet from Phillips at all. Any chance they will replace mine or am I out of luck?
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
With this sort of thing, assuming your serial #s are in the recall, then, yes, they should replace it.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
FDA U.S. Food & Drug Administration

The FDA has issued another update, it looks like a composite of previous updates.

Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions

UPDATE: On March 14, 2022, the FDA added information about Philips Respironics prioritized replacement devices in the How to Tell if Your Device Has Been Recalled and What to Do Next and What the FDA is Doing sections below.

On March 10, 2022, the FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company's June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines, and the unreasonable risk of substantial harm to the public health posed by the degradation of the polyester-based polyurethane (PE-PUR) sound abatement foam used in those products. The FDA has determined that this order is necessary to eliminate the unreasonable risk of harm posed by the recalled products because the company's notification efforts to date have been inadequate.

Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions | FDA
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RE: Update on Philips recall portal
(03-09-2022, 11:14 AM)chasmm Wrote: For example, I have three (3) machines on recall (System One, DS1, DS Go). Only one was purchased through a DME (System One), the other two were bought outright by me online. All 3 are registered, but Philips can only match 1 of the 3 to a DME. 

Almost the same boat. Received the replacement parts for a DS2 (my home machine) purchased through my current DME, received notice suggesting movement soon on the System One (which I use at my partners’ house) that I had purchased through my prior DME and has been matched, but the Dreamstation Go, which I really need for an upcoming trip, was purchased online and it has not been matched yet. 

Thinking about springing for a ResMed AirMini. (The Go battery - expensive extra - has deteriorated to the point where it’s tough getting a single night in.) Man, the prices on these and the gouging on things like the cases is painful when they have to be paid out of pocket.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Can Philips Respironics 'executive management' and QA people be held responsible for what appears to be criminal acts that caused personal injury?


FDA Inspection Report
On November 9, 2021, the FDA issued a report listing observations made by agency representatives during their inspection of the Philips Respironics facility in Murrysville, Pennsylvania. Among its damning findings are the following:

  1. Risk analysis is inadequate. The report said, “There is no documented investigation, risk analysis, or design failure mode effect analysis to support [Philips’] rationale for which polyester polyurethane foam-containing products were affected, included, or not included in [Philips’] ongoing recalls … A risk analysis is inadequate or was not performed when appropriate or within an appropriate time frame of [Philips] becoming aware of potential polyester polyurethane foam degradation and/or Volatile Organic Compound (VOC) emission concerns regarding various CPAP, BiPAP, and ventilator devices…[P]otential foam degradation in Trilogy ventilator devices is not an isolated incident, and [Philips] also ha[s] not documented a detailed rationale for why harm is not likely to occur again, as required by [Philips’] Health Hazard Evaluation’s instructions…DreamStation 1 device failed emissions testing for VOCs and Aldehydes, which was analyzed/ tested from 01/18/2019 to 01/25/2019. Specifically, Table 3 documents that the tolerable limits of the Formaldehyde compound were exceeded during initial operation[.][emphasis added]“

  2. Procedures for corrective and preventative action have not been adequately established. The report said, “No formal investigation, risk analysis, or CAPA [Corrective and Preventative Action] were initiated, performed, or documented, in response to the at least 222,000 complaints that could potentially be related to foam degradation and received from 2008 to 2017[.]”

  3. Design validation did not ensure the device conforms to defined user needs and intended uses. The report says, “‘The Trilogy user manual recommends the use of a bacterial filter for invasively ventilated patients or if the device will be used on multiple patients. This filter would catch any particulates released into the Trilogy airpath.'”

  4. Procedures for design change have not been adequately established. The report says, “This preventative maintenance procedure, the intended replacement component, or the [REDACTED] time frame were not verified, reviewed, or validated before implementation.”

  5. A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. The report says, “[There were] multiple field complaints and at least 1 Trilogy unit failure, caused by polyester polyurethane foam degradation. This affected foam was later found to be mutagenic, cytotoxic, carcinogenic, and non-biocompatible.”

  6. Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization. The report said, “[Philips] management, including management with executive responsibility, were aware of potential foam degradation issues concerning CPAPs, BiPAPs, and Trilogy ventilators since at least 01/31/2020, or earlier, and implemented no further corrective actions until April 2021.”

  7. Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established. The report said, “[Philips has] no established data, documentation, or written agreement that clearly describes or references the quality requirements of [Philips’] raw foam supplier[.]”

  8. Potential consultants were not evaluated and selected based on their ability to meet specified requirements. The report said, “Additionally, no Supplier Qualification Forms, Form 5077, were completed for the [REDACTED] consultants, as required per [Philips’] supplier quality procedures and work instructions.” Most troubling is the documentation showing that the DreamStation 1 emitted unsafe levels of formaldehyde, which is classified as a Group 1 carcinogen – the most dangerous. Formaldehyde can cause myeloid leukemia and cancers of the paranasal sinuses, nasal cavity and nasopharynx in addition to lung injuries.4
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Anyone else get another update e-mail today from Philips? I got two of them for my three registered machines (I haven't checked to see which machine I didn't get one for).

Today's update talks about the process, the new portal, and mentions to not use UV/ozone devices. I've copied the info below for those who may not have received it yet:

Quote:We listened to your recent feedback on the need for better, and more frequent, communication during the remediation process. To meet this need, we’ve created a new website with essential information in one place. Read on to learn more about new content and tools: 

  1. Information on the remediation process and your device status. We’ve added a patient portal where you can check your device status. Please be prepared to enter your registration confirmation number or serial number. You will also need to confirm your identity using your last name, zip code, and the last 4 digits of your phone number you used to register.  You can also learn more on the remediation process with our step-by-step guide.  
  2. How replacement devices are allocated. In addition to checking your device status, you now have the option to update your registration information through the Patient Portal.  We are prioritizing replacement device distribution based on this demographic and health information.  You can find out more about our approach to allocating replacement devices here.  We will begin distributing devices based on prioritization in the coming weeks once prior registrants have been given an opportunity to update their registration information. 
  3. A reminder on cleaning your device. Please be aware that both ozone and UV light cleaning products that claim to clean, sanitize or disinfect Philips devices and accessories have not been authorized by the FDA. As always, please be sure to follow the cleaning instructions in your device manual and only use approved cleaning methods. 
We will continue to provide regular updates to you through this process. In the meantime, as a reminder, your device registration confirmation number is 1234567890123456. 

Thank you for your continued trust.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Absolutely ridiculous that after 10 months now of Health Canada recalling Phillips products that they still have NO plan for making things right for affected Canadians.

Garbage company. I joined a class action lawsuit and I don't care if it's years down the line before I get compensation, but I expect Phillips to pay me back for a faulty machine. Despite my signature, I actually started off my CPAP journey using a Dreamstation and now it's just gathering dust.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(03-15-2022, 12:43 AM)Dafod Wrote: …. I am only exchanging the DS1 for another DS1 (In Aust the DS2 cannot be a replacement since it has not been reg)…

Also in Australia, I have an 11 year old REMstar Pro registered for replacement.

I wonder what Philips will provide?
I can’t see them repairing and re-using machines that old.

I have not heard anything from them since October.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
MEDTECHDIVE

FDA identified 28 suppliers unaware of Philips sleep device recall

The agency contacted 182 suppliers of recalled devices, and 28 said they were not aware of the recall. The FDA claims when it emailed Philips with the information, there was no response.

Published March 16, 2022

Last Thursday, the FDA released an order directing Philips to notify all of its customers regarding the recall of sleep apnea and ventilator machines, after the agency determined the company had failed to adequately communicate the recall and the health risks facing patients if affected devices were still used.

FDA identified 28 suppliers unaware of Philips sleep device recall | MedTech Dive
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