RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The environmental specifications in the System One and DreamStation owner's manual are identical:
Operating Temperature: 5° to 35° C (41° to 95° F)
Storage Temperature: -20° to 60° C (-4° to 140° F)
Relative Humidity (operating & storage): 15 to 95% (non-condensing)
Atmospheric Pressure: 101 to 77 kPa (0 - 2286 m / 0 - 7500 ft)
DaveCar used his DreamStation within Philips specifications.
How to expose yourself to offgasses and particles from the foam.
1. Operate the machine as specified.
2. Breathe.
Any questions?
08-14-2021, 07:51 PM
(This post was last modified: 08-14-2021, 08:18 PM by WakeUpTime.)
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
It would seem that 3-4M device users are in a troublesome state then, as most countries, associations and advisory groups for the moment just see:
- manufacturer announces recall, warning of defective product use
- manufacturer claims an extremely small number of registered complaints/injuries via "customers"
(generally speaking, no one ever opened their system units for inspection previously)
- manufacturer states that they'll eventually (over a significant period of time) repair the product
"Problem solved".
Actions need to develop to enlighten the public, the affected user community and those in positions of authority, on the reality of the faulty devices. In my opinion, a level of "injury" has occurred with the discovery of foam particles inside recalled devices - there has indeed been some foam ingestion. Those toxic components were never meant to be inhaled/ingested. Recalled device users, through any appropriate means, should be given individually their "right to know".
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-11-2021, 04:26 PM)cathyf Wrote: Is there anyone who has been in a hospital or sleep lab setting since the announcement of the recall where the hospital wanted to use one of the recalled Philips devices on a patient? What sort of legal jeopardy does that put the hospital in?
I just had to have a sleep study last night as it had been over 5 years since I got my Dreamstation and I'm trying to get a new ResMed Autoset 10/11. The sleep center was still using all Philips equipment and CPAP's that were part of the recall. They provided me with an information packet on the recall explaining the risks and the reasons for the recall. After reading the information(which I didn't lol, as I already know about it) It was my choice if I wanted to continue with the sleep study, if I did, I had to sign a paper stating that I understood the risks. However they specifically stated they have never used any type of Ozone cleaners or been exposed to high humidity, and they also use in-line bacteria filters for every study. Lol the sleep tech was surprised because I was the only one of their patients that knew everything about the recall and also the only one that had removed the foam from their machine haha. The tech was awesome and even hooked me up with a full new mask to try out and gave me a 2nd new cushion for it 
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
If you were the CEO of a medical device manufacturer with a newly discovered, major product flaw you have a choice. 1) Commit the company to complete disclosure, and a complete, fair and equitable solution (and compensation for your customers); or 2) delay and deny, seek to minimize cost and financial impact, until you decide what action(s) you might really want to take.
Will the real CEO of Philips please stand? Or, has he already.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-14-2021, 07:00 PM)SingingSam Wrote: The environmental specifications in the System One and DreamStation owner's manual are identical:
DaveCar used his DreamStation within Philips specifications.
And DaveCar got poisoned.
From philips:
Chemical emissions from the PE-PUR foam
Emission of certain chemicals from the foam has been identified, resulting from trace
amounts of organic compounds associated with the production process of the foam.
Based on standard ISO 18562-3 testing which ran a device at 35°C ± 2°C for 168 hours, two
compounds of concern were emitted from the device: dimethyl diazene and phenol 2,6-bis
(1,1-dimethylethyl)-4-(1-methylpropyl).
Foam Degradation
Despite a complaint rate of 0.03% (i.e. 3 in 10,000) in 2020 [1], Philips has determined
from user reports and lab testing that the PE-PUR foam may slowly degrade – through a
process called hydrolysis – and produce particulates which may enter the device’s air
pathway where they could be ingested or inhaled by the user of impacted Continuous
Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) and
mechanical ventilator devices.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-15-2021, 07:09 AM)oldgreenhead Wrote: If you were the CEO of a medical device manufacturer with a newly discovered, major product flaw you have a choice.
Will the real CEO of Philips please stand? Or, has he already.
It wasn't a newly discovered, major product flaw. They have known about this problem for years and internally excused it away.
The CEO of Philips and/or respironics board of directors should be cuffed, stuffed, and jailed.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The CEO of Philips and/or respironics board of directors should be cuffed, stuffed, and jailed.
I hear it gets REAL cold up around Leavenworth !
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I have previously stated that I am the owner of a recalled unit and I am angry with Philips and believe their response is woefully inadequate. I also believe that it is a very real possibility that Philips will exit this business as a result of this recall. However, I doubt that the officers or directors of the company are guilty of criminal acts. I am only interested in seeing Philips customers fairly treated and appropriately compensated for their financial damage and physical injury as a result of this design failure.
Medical device recalls occur every year in significant numbers. Three million units (or more) is nowhere near the largest such recall in FDA history. It's serious to us because we are personally impacted. Rhetoric that suggests that officers or directors belong in prison has no factual basis that I am aware of and is not helpful.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
For any Canadians who wish to discuss this issue, the email address for Britta Kroupa, President of Philips Canada, is britta.kroupa@philips.com. While she did not reply to my email, it did seem to have been forwarded to their support team, whose email is pcms.support@philips.com.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
We keep falling into the same trap that everyone else has, we are quoting what Philips puts out. I do not believe them, unfortunately, there are no other information sources.
A major manufacturer knows exactly how much product they have produced and how much was sold. When Philips says 3-4 million units, think about that for a second. They are just throwing out numbers that can't be verified.
My guess is that 3 to 4 times that number were sold in the US, if not more.
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