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

[SarcasticDave94]

IMO the ventilators would not work well as CPAP replacements, and not because it's a ventilator. Examples of ventilators I'm referring to: Philips Respironics Trilogy and ResMed Astral. They don't use your standard CPAP hose/air circuit. They also do not have an integrated humidifier, they're always an accessory on the NIV ventilator.

In other words, your hose will not work in most cases. Ventilator air circuits will likely cost a lot more than the CPAP variant.

Secondly, programming would need completely redone. Ventilators do have a simple CPAP mode, but it's likely straight CPAP like what the ASV does in that mode.

[Mosquitobait]

The CPAP and APAP machines are functionally replaceable with a DS2. Has anyone received a replacement bilevel or ASV machine?

Not yet. Bro is waiting on bipap replacements for his System One and Dreamstation one.  I'm guessing the repair kits are for those and other non-cpap since there is no Dreamstation 2 Bipap being made yet.

[Rice95]

Hi everyone

I haven't been in the loop of all the replacement info. I registered my DS1 the day after I found out it was hazardous. I bought a RESMED 10 Auto and have been using it ever since. 

My question is are they repairing or replacing or both?

[jas32]

Hi everyone

I haven't been in the loop of all the replacement info. I registered my DS1 the day after I found out it was hazardous. I bought a RESMED 10 Auto and have been using it ever since. 

My question is are they repairing or replacing or both?

From what I've read from recent postings the past several days, replacing with a new DS2 machine is all that is happening.  No idea on what order the new machines are being dealt.

[WakeUpTime]

We perhaps should devise an evolving Recalled Device Scheduler, perhaps in the Wiki, to give new followers a sense of where Philips is at in their Recall process.  Regrettably, Philips hasn't provided that.  It would give a summary update of the stage that Philips has entered with fixes/replacements.  

Knowing their current "filter" would be easy, but their "sort order" would merely be an estimate.  (Some might prefer that it be left out altogether.)  Some categories might have more than one outcome, and of course there are multiple countries involved too.  It might be too complicated and perhaps the Board will be concerned that a predictive estimator wouldn't be a good idea.  

It would only announce the stage that Philips has entered and known outcome scenarios, rather than provide and definite direction of Philips Policy.  We'd really like those that have had results to update us on their Philips PAP device model so that we can always have a clear picture of where Philips is at.  Of course, there will be exceptions (e.g. airline pilots) who may get a more immediate response from Philips, regardless of their device category.  A spreadsheet would be perfect.  I'm sure that one already exists, or soon will exist, on another site.  Many would like that, including users, the media, doctors, lawyers, etc.  Philips may eventually disclose their version.  Perhaps they've already provided one to the U.S. FDA and other agencies.

Is this where Philips is at now?

COUNTRY / DEVICE TYPE / SUBSET / START DATE / DEVICE UPDATE / POSSIBLE SORT ORDER

---

US / DreamStation 1 CPAP / DreamMapper Updated / Sep-1-2021 / New DS2 Direct to Owner / Recall Registration Date (est.)
US / DreamStation 1 APAP / DreamMapper Updated / Sep-1-2021 / New DS2 Direct to Owner / Recall Registration Date (est.)


I think we still don't know how Philips will handle DreamStation 1 CPAP/APAP devices that don't have recent device pressure settings stored in the Philips Cloud.  We also don't know where Philips is at with new DreamStation 2 models that have yet to be announced (e.g. DS2 BiPAP, etc.).  Philips received FDA approvals for those DS2 models. If they're producing them shortly, they may also receive replacements.  Alternatively, they could receive service updates with new foam.

[DaveCar]

When Philips said they are producing repair kits, could they be more for the hospital-type units ? A worker at our local hospital told me that she noticed an audit of sorts was done wrt the foam/Philips machines.

[btreger]

Note: Some of this information may have been previously posted.


Philips Faces Inspections and Potential Fines, As FDA Monitors CPAP Recall Repair/Replacement Program


In response to Frequently Asked Questions, the FDA provided information on Friday about the manufacturer’s plans for repairing and replacing CPAP machines. The agency also indicates Philips will face inspections, monitoring, and could face potential fines as it works to address problems caused by a toxic polyester-based polyurethane (PE-PUR) sound abatement foam used in millions of devices sold in recent years.

However, the agency also noted Philips Respironics has not yet given the agency all of the information it needs to evaluate its plans to repair all breathing machine devices affected by the recall, such as Trilogy ventilators, A-series BiPAP machines, and others.

In addition, the agency announced in the FAQ that it has initiated on-site inspections of Philips Respironics’ manufacturing facilities in order to determine whether they are in compliance with federal regulations and said the company could potentially face fines and other penalties.

Note: If the FDA is really doing on-site inspections that is very good news for every one of us. There is still no information on the new foam being used in the DS2 or has any testing been done on it? This should be a major concern considering Philips's total disregard for human health over at least 10 years. 

[WakeUpTime]

...[The FDA] has initiated on-site inspections of Philips Respironics’ manufacturing facilities in order to determine whether they are in compliance with federal regulations and said the company could potentially face fines and other penalties.

I wonder what that actually means, from an action point of view.  What would an FDA representative be looking for?  There are severa; different types of recall facilities: those producing new systems, those producing the repair kits, and those service centers performing the update on the used systems.  The repair kit is merely a little piece of foam in a plastic bag with a label.  I suppose they could be looking at the replacement foam inventory and being sure that it matches the quality that Philips has stated in their new foam.

I could see the FDA being very interested in the repair facilities, likely existing with third-party contracted companies.  There would be a lot of reasons to continuously analyze those facilities.  The FDA could...

• analyze the foam being removed, possibly keeping it
  
• analyze the hygienic process and thoroughness of the repair to ensure updated systems meet standards
  
• analyze the skills demonstrated by the repair technicians
  
• analyze the production rate
  
• etc.
  

The FDA has an opportunity here to improve their reputation a bit.  Let's see what they do with that opportunity.  Let's see if they're looking out for the best interests of consumers, or politicians, or corporations.

I find it insulting and disturbing that Philips has not informed the FDA on how it intends to deal with all other recalled devices, beyond its current focus on DreamStation 1 CPAP/APAP owners with updated cloud settings.  The FDA chief should demand an immediate meeting with the Philips chief to obtain those details, for the satisfaction of the FDA, let alone device owners.  It's incredible that, more than 3 months later, the FDA still hasn't secured those details.

[LindanHotAir]

I just received a DS2 from FedEx. It has a heated humidifier and it came with a power cord, power brick, standard 15mm tubing (unheated), a washable filter (installed), a fine filter (not installed), a Patient Quick Start Guide, and a Dreamstation 2 CPAP Advanced/Auto CPAP Advanced User Manual. The bag containing the manuals had a link for the clinical manual but a login and password was required for that part of the site. The printing on the bag showed model numbers DSX420 and DSX520 for the CPAP and Auto CPAP.
Nicko told how to access the clinical menu: Hold the start button until the ring around it blinks (about 3 seconds) then swipe down the touch screen.
When I powered up the machine it indicated it was downloading my settings. It was set to 12.5 - 20. I don’t remember using those settings. The ramp settings were rather cryptic. There is a selection of 15, 30, or 45. It appears that you turn it off by selecting a time and selecting the + on the pressure and increasing it until it rolls to 0. (It looks like there is more than one place to set the ramp).
The humidifier has settings of off and 1 through 5 but appears to be missing the A adaptive setting from the DS1.
It has a slot for a SD card but no card was supplied.
I am in the Pacific Northwest.

[btreger]

Former FDA Commissioner Scott Gottlieb joins Pfizer’s board of directors


Scott Gottlieb, who stepped down as Food and Drug Administration Commissioner in April, will join Pfizer’s board of directors, the company announced Thursday.

Gottlieb resigned from the FDA this spring after nearly two years at the helm. During his tenure, Gottlieb advanced a number of prescription drug policies, including pushing the FDA to speed up generic drug approvals and use its powers to encourage wider use of biosimilars or copycat versions of complex and often costly biologic drugs.

Note: Could this be an indicator of how the FDA might be treating Philips? Everyone is just looking out for themselves and keeping all their future options available by not going too severe on Philips. It does seem they all have relationships with the manufacturers they have a responsibility to oversee. All we have gotten from both Philips and the FDA are bullet points, no real or complete details.