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

[btreger]

Back in August U.S. Senator Richard Blumenthal released a one-time news briefing on behalf of Connecticut residents relating to Philips and the recall.


He released a multipage document of questions he expected Philips to respond to by early September. The Senator never spoke again on this subject, and every attempt to contact his offices was met with total silence, and Philips's response was never released.

He is now back in the news, at least for one press release;

Senator Raises Alarm URGENT FDA ACTION TO PROTECT AGAINST DEFECTIVE PHILIPS BREATHING MACHINES

[HARTFORD, CT] – Following a new federal investigation revealing that a fix to the Philips sleeping machine recall poses significant risks to patients, U.S. Senator Richard Blumenthal (D-CT) and Connecticut Attorney General William Tong called on the U.S. Food and Drug Administration (FDA) to take immediate action to protect millions of Americans—and thousands of Connecticut residents—impacted by the recall of Philips CPAP, BiPAP, and other ventilator machines. Blumenthal and Tong urged strong FDA action at an event earlier today with affected Connecticut residents and a local doctor.

Senator Raises Alarm URGENT FDA ACTION TO PROTECT AGAINST DEFECTIVE PHILIPS BREATHING MACHINES - DoingItLocal

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UPDATE


MDL 3014 In Re: Phillips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation

ORDER APPOINTING CO-LEAD COUNSEL, PLAINTIFFS’ STEERING 
COMMITTEE, CO-LIAISON COUNSEL, AND CERTAIN COMMITTEE AND 
SUBCOMMITTEE CHAIRS AND MEMBERS

WHEREFORE, this court reviewed the 75 applications for co-lead counsel, Plaintiffs’ 
Steering Committee (“PSC”), or liaison counsel (collectively “plaintiffs’ leadership”), and 
conducted a videoconference1 interview of each applicant during which the court had the 
privilege to learn about each applicant’s impressive relevant professional experience and the 
contributions he or she may offer to the plaintiffs and the court in this multi-district litigation 
(“MDL”),

WHEREFORE, this court was informed by many of the applicants that this MDL is 
expected to be expansive and include complex and diverse issues of fact, science, and law
because of the class action, medical monitoring, and personal injury claims asserted by the 
plaintiffs in this case, 

3014_Pretirial_Order_8.pdf (uscourts.gov)

[ST Dog]

[HARTFORD, CT] – Following a new federal investigation revealing that a fix to the Philips sleeping machine recall poses significant risks to patients, U.S. Senator Richard Blumenthal

Typical politician. It did no such thing.

It questioned the teat results, and asked for new testing, but the FDA did not say that the new foam poses a significant risk, or any risk.

It it had they would have stopped the sale and use of the DS2 and stopped the replacement program and told everyone to quit using the replacement machines.

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The French National Agency for Medicines and Health Products Safety (ANSM)

Philips Respironics ventilation devices: ANSM takes a health policy decision to speed up the replacement of certain devices

In France, 370,000 patients are concerned.

The replacement plan for all the affected devices announced by the manufacturer has made very little progress. As of February 4, 2022, Philips Respironics had replaced only 7% of the defective devices.

Therefore, Philips Respironics is bound by our animal health decision to accelerate the replacement of machines in the following ways:

-the replacement with service providers or the repair of 75% of the devices concerned in June 2022;
-the replacement with service providers or the repair of 100% of the devices in December 2022.

Philips Respironics is also required to:

-to send each month to the ANSM a progress report of the calendar;
-to set up an epidemiological study to assess the risk of cancer potentially induced by exposure to the ventilation equipment concerned, the preliminary results of which must be transmitted to the ANSM at the latest within one year.

News - Philips Respironics ventilation devices: ansm takes a health policy decision to accelerate the replacement of certain devices - ANSM (sante.fr)

[hegel]

Good to hear that Philllips is bound by France's animal health decision. Put 'em on a leash while we're at it!

[pholynyk]

One suspects a mis-translation or possibly a typo...

[btreger]

One suspects a mis-translation or possibly a typo...

Right, the original article was in French. I did not think that would go over too well as a post. I did a translation through my browser and posted the results.

[ST Dog]

In France, 370,000 patients are concerned.

As of February 4, 2022, Philips Respironics had replaced only 7% of the defective devices.

-the replacement with service providers or the repair of 75% of the devices concerned in June 2022;
-the replacement with service providers or the repair of 100% of the devices in December 2022.

So go from 6.5k/mo (7%, 26,000 in 4 months) 
to 50k/mo (251,600 in 5 months).

Sounds perfectly reasonable.

Just redirect from other countries, no one cares about the people there.

Oh maybe other countries will issue similar edicts.
Then Philips can magically increase producton by 10 fold (to also meet demand for new users). They can buy a refinery to make plastics and a fab to make semiconductors

[hegel]

Yes, the "animal health decision" is clearly a mistranslation. I was making a joke. It's often hard to tell!

And yes, given covid, difficulties in hiring, supply chain issues and a worldwide chip shortage, it's not that easy to ramp up production by a factor of 10 in order to meet the immediate demand/need of cpap users. I imagine that Resmed is trying to ramp up production too. I wonder how that's going? that's a real question, not rhetorical. They certainly have an opportunity now to sell a lot of machines!

[sawinglogz]

I read a report that the supply chain issues were affecting them pretty significantly too, especially because they place smaller orders than Philips.