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

[WakeUpTime]

The FDA doesn't seem to be happy with Philips communications to patients regarding the Philips Recall.  They've made it a major discussion topic at their next FDA Conference in October:

"FDA Patient Panel To Grapple With Recall Communications"
MedTech Insight
August 10, 2021

The US FDA’s Patient Engagement Advisory Committee will discuss Best Practices for Recall Communications aimed at patients, as well as related topics, at an October forum.

[mrmagloo]

Well it sure would be nice to have a consumer advocacy representative present that will push to get full refunds for patients in light of the horrid response experienced to date.

[cathyf]

They would have much more to lose than me, in refusing to fix/replace a faulty recalled medical device.  That certainly would be an incredible headline.

I agree -- American civil juries have extraordinary punitive powers, and the American legal system is quite supportive of suing companies out of business entirely when the jury finds the defendant recklessly indifferent.

And if I were going to use any phrase to describe Philips' behavior so far, "recklessly indifferent" would be it. As in recklessly indifferent to the harms they have and/or potentially might cause the patients who use their devices.

[cathyf]

Question for the hive mind here: I've had two sleep studies at the little hospital in my town. Neither included a titration, but there was some variety of identifiable PR version (probably the ASV) on the night stand in the lab.

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?

[btreger]

The FDA doesn't seem to be happy with Philips communications to patients regarding the Philips Recall.  They've made it a major discussion topic at their next FDA Conference in October:

It's about time the FDA has come forward with new information. I think enough pressure has been building up that required them to do this. They do not want that pressure, and I think we now know where the soft spot is concerning the recall. If you want to complain about this disaster of a process, go to the FDA, and do not waste your time going to Philips. The FDA owns this.

This is from their June 30 announcement:

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

FDA Actions 

The FDA is working to assure Philips Respironics adequately evaluates the issue with the device, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by the company.

The FDA is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue.

The FDA will continue to monitor supply and demand to assess the availability of the affected devices and any potential shortages.

The FDA will continue to share updates with the public as more information becomes available.

[btreger]

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?

The AASM has reported that Sleep Centers that are still using Philips devices, must explain the known hazards associated with that device and have the patient sign a waiver.

I know the Sleep Center I went to 8 years ago has switched to ResMed AirSense 10 devices now. When you leave, you keep the hosses and the mask.

[Gideon]

This is totally unofficial. it is from a Reddit user post, I do not know the validity of this.  It is the first positive sign on the recall, nothing more.

[color=var(--posttitletextcolor)]Dreamstation replacements will begin shipping soon
[/color]

I received this update from a local DME. Nothing has been updated on the official website though.
UPDATE 8/10/2021
After 8 weeks we have finally received additional information regarding the Phillips/Respironics CPAP and BiPAP recall. Phillips is planning to start shipping their first wave of replacement CPAP devices within the next 7 business days. We have not yet been notified as to who will be receiving them or how long it will take to mitigate all the affected devices. However, if you are one of the individuals who will be receiving a device in the first wave of replacement units, you will be notified directly by Phillips and given additional information on how to complete the process. Philips will have multiple waves of replacements that will happen over time and in each case you will be contacted directly by Philips with instructions on what to do.

[SleeplessinPgh]

Wow.  If the info in post 1,077 is correct, it's definitely a step forward.  Thanks!

[btreger]

This is totally unofficial. it is from a Reddit user post, I do not know the validity of this.  It is the first positive sign on the recall, nothing more.

After reading this I contacted the two CMEs, I work with. One is through insurance and the other is for cash. Both gave me the same story they have no new updates, and that I should contact Philips.

[PUNJABI408]

This is totally unofficial. it is from a Reddit user post, I do not know the validity of this.  It is the first positive sign on the recall, nothing more.

I just spoke with my Local DME and they told me the same thing. Philips will start replacing machines for people who registered their device online.  Right now this is only for people who registered their own devices, not for DME or people who the DME registered to handle the replacement. Another thing that can help speed up the process is if your machine is if your machine is connected to Care Orchestrator through either a cell modem or wifi.  My DME said as of right now Philips will use Care Orchestartor to get pressure and information about the machine, so replacements devices can be set to those settings.   My DME also said this is not official and they will know more by Monday.