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

[TimaaaaaaaahRocks]

"An analysis of consumer complaints sent to the company revealed that since 2008, Philips Respironics had received "over 222,000 complaints" that included the keywords "contaminants, particles, foam, debris, airway, particulate, airpath and black."

Those words also appear in your post, so add them in. "Airpath" can occur in a hundred different unrelated contexts; same with "black" (I don'[t like the black color of my machine"); same with "airway" "debris" and all the rest. I'm curious about the source of your long quote. I'm assuming it's from lawyers suing PR. Fair enough. But the "222,00 complaints containing key words" bit is ridiculous. JFK used the word "Monroe" 700 times in his speeches. Obviously he was having an affair with Marilyn Monroe! (Oh, wait he was referencing the Monroe doctrine.) Context!!

(Yeah, he really did have an affair with Marilyn, but you see my point).

No i don't see your point, pure ignorant drivel, and you assume wrong. "According to the FDA’s inspection" means, well, According to the FDA’s inspection. Reading is fundamental:

fda dot gov/media/154099/download


Context!! - multi-billion dollar medical device maker ignores FDA rules for design/root cause defect analysis and fails miserably.

[SuperSleeper]

Let's try to keep this thread on-topic (regarding the Philips recall), and to keep it civil and without personal attacks.  No one has yet violated the forum rules, so let's keep it that way.

Just a reminder.  Thanks folks.  

[hegel]

"No i don't see your point, pure ignorant drivel, and you assume wrong. "

I run into this so often on the internet. People think they can refute a point by insulting the person they disagree with. Yes, let's keep it civil! Try using reason next time and reply to the point.
Again: keywords like "black" and "airpath" appearing in a complaint doesn't necessarily mean that the complainant was writing about foam degrading. How hard is that to understand?
sheesh.

[WakeUpTime]

It seems Philips isn't in any financial danger, given that it sold US$20 Billion in their previous year.  Its total costs related to the recall will likely be US$1 Billion as a corporate write-off, spread over several years.

"Philips, still hobbled by expanded ventilator recall, braces for Q4 earnings miss"
https://www.fiercebiotech.com/medtech/ph...nings-miss

At the root of Philips’ troubles are the ventilator recall, global shortages of electronic components and freight capacity and delays in the installation of its medical devices. All together, those issues added up to an impact of five percentage points on full-year comparable sales, the company said.

“We continue to see good demand for our innovative products and solutions, resulting in an all-time high order book,” CEO Frans van Houten said in a statement. “However, we faced significantly intensified global supply chain issues across our businesses, in addition to customer postponement of equipment installations in hospitals. We are closely working with suppliers and governments to address the shortages in the healthcare supply chain and ensure they recognize the importance of prioritizing life-saving medical equipment.”

With those lower-than-expected numbers closing out the year, Philips is now expecting full-year sales to total about 17.2 billion euros, or about $19.7 billion—a 1% drop from last year.

At the root of Philips’ troubles are the ventilator recall, global shortages of electronic components and freight capacity and delays in the installation of its medical devices. All together, those issues added up to an impact of five percentage points on full-year comparable sales, the company said.

Additionally, details from btreger's earlier WSJ news post...

"Sleep-Apnea Machine Recall Costs Grow, Hitting Philips Shares"
Dutch healthcare giant now expects recall to affect around 5.2 million devices, says supply-chain woes have weighed on sale
THE WALL STREET JOURNAL
https://www.wsj.com/articles/philips-sha...1641993565

Patients suffered fresh anxiety in November when the Food and Drug Administration raised concerns that the silicone foam used in the repaired or replaced devices could also release harmful gases. The FDA asked Philips to hire an independent laboratory to run further tests on devices using the new foam to identify any potential safety risks.

Philips also said Wednesday it would raise the financial provision related to the recall to €725 million, equivalent to about $824 million, up €225 million from the amount it had previously set aside. This mainly relates to the costs of the repair-and-replace program. It doesn’t include any costs from potential legal action arising from the recall.

[TimaaaaaaaahRocks]

(A CAPA is required when there is a single complaint and a corrective action must be initiated if the analysis determines there is a safety problem. Read the report. It is absolutely shocking to think that any human being(s) could ignore evidence that the machines were pushing toxic particles into a patients lungs. The foam failed bio-compatibility tests in several products an they kept using it.)


https://www.fda.gov/media/154099/download

From the report:

Your firm is currently conducting on-going, Class 1 medical device recalls of over 15 million Philips Respironics ventilator, CPAP, and BiPAP devices, due to polyester polyurethane foam degradation and volatile organic compound emission, which was publicly announced on 06/14/2021.

c) Analysis of quality data, such as complaints and medical device reports, was not adequately performed to identify or detect quality problems.

1. No formal investigation, risk analysis, or CAPA 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, prior to the initiation of CAPA INV 0988 in 2018. CAPA INV 0988 was initiated on 04/ 12/ 2018 in response to field complaints alleging foam degradation on Trilogy ventilator devices, and CAPA 7211 was initiated on 06/ 19/ 2019 in
response to field complaints alleging foam degradation on ventilator, CPAP, and BiPAP devices. A query of your firm's consumer complaints from 01/01/2008 to current, for the keywords contaminants, particles, foam, debris, airway, particulate, airpath, and black, resulted in over 222,000 complaints, and over 175,000 of which occurred between 2008 to 2017. Alternatively, no formal investigation, risk analysis, or CAPA were initiated, performed, or documented, in response to the at least 175,000 complaints potentially related to degraded foam, prior to CAPA INV 0988, initiated on 04/12/2018. 

---

CFR 21 § 820.198 Complaint files.

© Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

[hegel]

"...that could potentially be related to foam degradation and received from 2008 to 2017..."

Note the repeated use of the phrase "could potentially be related" throughout. Doubtless their large number of potential complaints is derived by using keywords such as "black" "airways" etc. and then counting everything that came up and calling it "potentially related" to complaints about the foam. Again, investigators would have turned up a lot of mentions of "Monroe" by using the same methodology with JFK's papers, and then say every instance of its use was "potentially related to Marilyn Monroe". Of course, the Monroe Doctrine was in effect at the time and much discussed.

I imagine a lot of things written to PR will use the word "Airway" and even "Black", given the machines...are black.

[btreger]

RE>above post<


This information was posted on 11/13, post # 1692

[Sleeprider]

btreger, it is useful to post the link rather than just the post number. My post numbers may vary from yours. This is post 1920 by my counter.

[btreger]

Sleeprider, thanks for that info. Did not know that. Then how do you reference an old post that does not contain a specific link?

[Crimson Nape]

Right-click on the post number, upper right of the post, that you want to reference. Select "Copy Link". In your new post, add "Insert a link" and paste the URL in the popup box. You will have the option to name this link shortcut, something else like, "[Reference Post]".

I have done this for you post above:
Test link - Click on me!