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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 - 12-24-2021
Philips Recall Update - Safety Results For DreamStation
Dec 23, 2021
https://www.youtube.com/watch?v=BsqszvDhm0U
Merry Christmas
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-24-2021
RE>above<
AP NEWS
December 23, 2021
Philips provides an update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*
December 23, 2021
https://apnews.com/press-release/globe-newswire/technology-business-health-europe-netherlands-1c01b12a892636d0a9ad4a51c8c4a6ea?fbclid=IwAR0HXYppEXbIjAGKbVOZdLqcBYmyfgLN6sSZ8XNs3yMAWeknBD2aEUTQo6I
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-24-2021
(12-24-2021, 12:08 PM)btreger Wrote: RE>above<Remember this is a Philips document. No one else has seen the test or confirmed the results they are offering.
AP NEWS
December 23, 2021
Philips provides an update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - Moriarty - 12-25-2021
(12-24-2021, 12:08 PM)btreger Wrote: RE>above<
AP NEWS
December 23, 2021
Philips provides an update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*
December 23, 2021
https://apnews.com/press-release/globe-newswire/technology-business-health-europe-netherlands-1c01b12a892636d0a9ad4a51c8c4a6ea?fbclid=IwAR0HXYppEXbIjAGKbVOZdLqcBYmyfgLN6sSZ8XNs3yMAWeknBD2aEUTQo6I
Yeah - right…
I think that was pretty much ‘non-news’…. It can’t be called ‘fake-news’ because what they said may be true but actually tells us nothing.
It certainly isn’t enough to stop me buying a Resmed to replace one of my DS-1 machines while I am waiting for them to actually do something.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - ST Dog - 12-25-2021
(12-24-2021, 11:58 AM)btreger Wrote: Philips Recall Update - Safety Results For DreamStation
Dec 23, 2021
https://www.youtube.com/watch?v=BsqszvDhm0U
Merry Christmas
Link to the Philips release since the AP story didn't include one.
https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20211223-philips-provides-update-on-the-test-and-research-program-in-connection-with-the-cpap-bipap-and-mechanical-ventilator-recall-notification
PHILIPS' RECENT E-MAIL - WakeUpTime - 12-27-2021
A new e-mail recently arrived from Philips related to the above Philips-commissioned ('independent') testing company's initial findings on just the off-gassing of toxic compounds for the majority of Philips ventilator products - although as mentioned above, it's only concerning DS1 devices.
I'm not sure how the Philips-commissioned testing company will be able to effectively test for the impact on several million patients of various pre-existing health conditions, ages, environments, ventilator models, ownership times, pressure conditions, environment temperatures and humidity levels, future health illnesses, etc.
Philips would like to assure us that they've successfully found, and paid significantly for, an 'independent' testing company that thinks they can successfully estimate an accurate long-term health prognosis for all Recalled device owners.
More than half a year later, we're receiving positive reassurance with the following:
Quote:
Thank you again for registering your Philips device. We want to assure you that we have your information. Your device registration confirmation number is xxxxxxxxxxxxxxxxx.
We are working as quickly as possible to remediate every affected device. In the meantime, we want to be sure you know where to go for important information. You can visit our Patient Information page. We’ve recently added some quick tips. Be sure to check back regularly for continued updates.
We appreciate your patience.
Thank you.
![[Image: philips_309x103.png]](https://www.cfmedical.com/storage/images/philips_309x103.png)
The Philips provided link, also provided earlier in the thread and in the Philips Recall Wiki, is applicable to Recalled device owners in the U.S. only is https://www.usa.philips.com/healthcare/e/sleep/communications/src-update/information-for-patients-and-caregivers.
Note (1): The phrase "every affected device" does seem to conflict with the Financial Times interviewed Philips CEO's comment that they would not be fixing "shelved" Philips ventilators. The implied meaning of such 'may' be ventilators in the following categories: not actively used, not a patient's primary ventilator device, not devices that haven't provided recent data updates to the Philips Cloud, not devices that are not currently owned by the initial purchaser, not devices that aren't 'managed' by a current Philips registered DME, etc. Therefore, non-DS1 Recalled devices, used for backup, travel, etc., 'may' never be upgraded.
Note (2): We should be reminded that the term 'remediate' means "provide a remedy for". That may mean, but isn't limited to, the following: replace the foam, replace the entire system, or provide a purchase refund. Potentially, one might also add 'forced compensation through legal judgement'.
RE: PHILIPS' RECENT E-MAIL - btreger - 12-27-2021
(12-27-2021, 12:49 PM)WakeUpTime Wrote: Therefore, non-DS1 Recalled devices, used for backup, travel, etc., 'may' never be upgraded.
Note (2): We should be reminded that the term 'remediate' means "provide a remedy for". That may mean, but isn't limited to, the following: replace the foam, replace the entire system, or provide a purchase refund. Potentially, one might also add 'forced compensation through legal judgement'.
I received the same e-mail, and I have a DS GO, (travel) machine. I think everyone that is registered and confirmed will be getting that e-mail regardless of its type or current status. Like you said everything that has been done relates to DS1 machines. I have no illusions that I will get anything from Philips.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - DaveCar - 12-27-2021
Sounds like they've now acquired a few months worth of data on new machines , which is better than the original "test" of what would amount to approx 21 days of usage.
Highly unlikely that they would test 2 or 5 years old machines returned from users, since that would be an unscientific approach (unknown variables). By testing 24x7, they could hit a 5 year representation after about 1.5 years. Real-world users will need to wait for test data that is representative of their own exposure.
I like the idea mentioned previously that they may be forced to store the returned foam from users for future evidence, but there would be a chance later on that any evidence is unreliable due to ageing of the sample, no ? (similarly for those who are keeping their machine as "evidence".. Philips could say the foam degraded in storage at the user's home)
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-27-2021
(12-27-2021, 02:00 PM)DaveCar Wrote: Sounds like they've now acquired a few months worth of data on new machines , which is better than the original "test" of what would amount to approx 21 days of usage.
Sounds like are the keywords here. I said this several posts ago, "Remember this is a Philips document. No one else has seen the test or confirmed the results they are offering". The FDA requested they do further testing, so you would expect they would first show the results to them, before being released to the media. All this might have been was something intended for shareholders, who really knows.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 12-27-2021
MDL 3014
Doc # 2
©with respect to the insect-infested DreamStation 1 Devices, if not returned to the
sender, Respironics must retain a record of all insect-infested DreamStation 1
Devices of which it disposes of, record, and retain a list of the sender and—if
reasonably possible—user of the DreamStation 1 Devices, and take a photograph
of the insect-infected DreamStation 1 Devices; Respironics, however, is not
required to preserve the insect-infested DreamStation 1 Devices;
Here we have Philips lawyers telling the judge that returned DS1's in their care have become infected with insects. The judge is reminding them to retain a record of the users and take photos. They are not required to preserve those devices. There is no info provided that would show how many of the DS1's returned have this problem.