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

[ST Dog]

My pacemaker is only about three years old. I suspect that recent pacemakers have improved shielding so microwaves aren't a problem.

Good to hear. Wonder when that changed. I looked an didn't readily find info on the change.
Technology has changed at a break neck pace over the last 40 years.

I still remember the signs in the 80s, but I spent far too much time in that VA canteen while dad was was there.

[ST Dog]

Microwave ovens and permanent magnets, two very different things.

Yes, but they are both sources if interference that could affect devices like pacemakers and internal defibulators.

That was my sole reason for mentioning them. Users of such sensitive devices have to keep track of what they are around.
There are lots of sources of RFI and magnetic fields, especially today with the abundance of strong rare earth magnets. 

And Philips warned about it. Cross post from the other thread:
-----------
For example this manual from 2017 for the Wisp
https://www.documents.philips.com/doclib...or_Use.pdf

on page 2

If your mask contains magnetic headgear clips, the following warnings apply:
 • The headgear clips contain magnets. Contact your healthcare professional before you use this mask.
 • Some medical devices may be affected by magnetic fields. The magnetic clips in this mask should be kept at least 2 in. (50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.
 • Do not use in or near magnetic resonance imaging (MRI) equipment.
------------

Now they are calling out more specific devices, adding static services.
And they are increasing the recommended distance.

But 14 issues out of 17 million masks? Barely worth mentioning, 0.0001%.

[btreger]

yahoo/finance


REUTERS

French prosecutors probe Philips respirator recall

PARIS (Reuters) -French prosecutors said on Thursday they had opened a preliminary investigation into a respiratory device recall by Philips, as the Dutch firm's legal problems over the device spread from the United States to Europe.

The Paris public prosecutor's office has "taken up, as of June 20, 2022, complaints filed on the grounds of aggravated deception, involuntary attacks on physical integrity, endangerment of the life of others, and administration of harmful substances," a spokesperson said in a text message.

French prosecutors probe Philips respirator recall (yahoo.com)

[WakeUpTime]

Interesting to see 3 new negative news stories for Philips in just the past week:

(1) Philips Recalling 17 Million Sleep Apnea Masks
(2) Additional Philips BiPAP Machines Recalled Due to a Plastic Issue
(3) French prosecutors investigating Philips Respironics Recall

The financial costs within the Philips ventilator division just continues to get worse.  It'll be interesting to see how successful Philips will be at actually selling (for money) future Dreamstation devices next year.

I also just received my second letter from "Philips" (likely a 3rd party) to submit my doctor's details and date of birth so that they can contact my doctor to obtain my prescription details for my other (second) Recalled Philips system.  It's likely only a matter of time before that database (likely shared within 2-3 companies) becomes the target of a 'hack'.

[btreger]

Interesting to see 3 new negative news stories for Philips in just the past week:

(1) Philips Recalling 17 Million Sleep Apnea Masks
(2) Additional Philips BiPAP Machines Recalled Due to a Plastic Issue
(3) French prosecutors investigating Philips Respironics Recall

You could have added a fourth story to your list:

  (4) Philips CEO Steps Down Amidst Massive Recall (Maybe he already knew about the first 3 stories to come out)

[pswartz]

We have three BiPap Auto 960P / System One 60 machines which were registered over a year ago. Finally, 2 of them have been matched and “assigned to a DME for fulfilment”. The problem is that other than my main machine, which I did get from a DME many years ago, the others were acquired “used” so I have no idea which DME they were matched to .

So, I called Apria, the one where I got my machine originally. They told me that they are NOT handling device recalls and further, not selling any Phillips machines.

I then called Phillips – not the Recall number, but one of the customer care numbers. They were actually very helpful, apologetic, and informative. They told me which DME’s my three machines were fulfilled through, and that the replacements would come from Phillips and not the DME’s (even though the status page says otherwise). They indicated that they are close to providing BiPap Auto replacements and that once shipped, the tracking numbers will be posted on the Status page. They said by end of year.

Two contacts for folks if they are interested: Phillips customer care 1-844-537-2403 and pcms.support@philips.com. Both phone and follow-up email were helpful.

[TwoSleepy]

I don't remember seeing Phillips August 11, 2022 "Testing update for patients" posted Testing update for patients (philips.com)
[url=https://www.usa.philips.com/healthcare/resource-catalog/landing/experience-catalog/sleep/communications/src-update/news/testing-update-for-patients][/url]
Note: this is not in defense of Phillips - I am unlikely to use any machine they may send me - but to whatever degree their information is accurate, it is at least a little encouraging to those who breathed through their machines for years. Two sections in particular.


"Results of particulate matter testing

 
To date, more than 60,000 DreamStation 1 devices that were returned have been inspected. 

Of these, 99.5% of devices not cleaned by ozone methods showed no foam particulates. In contrast, 7% of ozone-cleaned devices had visible foam particles. This was 14 times higher than in non-ozone-cleaned devices. 

Similarly, inspection of about 2,000 devices returned from Europe showed no significant degradation. 

As the PE-PUR foam degrades, its foam shrinks, becomes sticky, but does not necessarily break down into particles. Additionally, the PE-PUR foam particles accumulate within the device and may not be emitted."

"Results of volatile organic compounds (VOC) testing



 
Exposure to VOCs from new, used and laboratory-aged foam in the DreamStation 1 devices is not expected to result in long-term health consequences for patients. Both new and used devices with visible foam degradation met international standards for limits of emissions from the particulate matter."

[WakeUpTime]

I don't remember seeing Phillips August 11, 2022 "Testing update for patients" posted 

It was posted and initially discussed earlier in this thread (see Page 219) when results of the June 28, 2022, test results (from the Philips appointed 3rd party testing agency) were first published by Philips.  [Ref: http://www.apneaboard.com/forums/Thread-...S?page=219]

There are many criticisms to the Philips study including the fact that these devices weren't randomly selected from users in the field.  They were the Recalled devices from the early part of the Philips Recall.  Although Philips says they include a range of devices, I don't believe they specified exactly what the % was for each device category.  It's my understanding that foam breakdown varies with age, usage hours, machine humidity, climate humidity and pressure, machine pressure, varying pressures (e.g. BiPAP, ASV), model (Dreamstation, System One, Go), and so on.  If I recall correctly, the early part of the Philips Recall saw relatively new DreamStation 1 CPAPs and APAPs replaced.  Philips admits that the study also analyzed new (unused) DS1 inventory stock from dealers with little no usage hours.  

It's preposterous for Philips to make their claim below, however it's not surprising considering there are several billion dollars in costs at play (direct Recall costs, lost current sales, impacted future sales, liability costs for corporate misconducts, user health liabilities, etc.).  I'll give significantly more respect to much more 'independent' studies that come out in the coming months as a result of the class-action lawsuits.

[Philips Press Release] "Exposure to VOCs from new, used and laboratory-aged foam in the DreamStation 1 devices is not expected to result in long-term health consequences for patients. Both new and used devices with visible foam degradation met international standards for limits of emissions from the particulate matter."

[TwoSleepy]

Yes, I recognize the discussion now. Oh well, if I hadn't been on CPAP for the past 20+ years, I'm sure my memory would be even worse.

[btreger]

REUTERS


Dutch shareholders threaten to sue Philips over recall, in a new media report

AMSTERDAM, Sept 12 (Reuters) - Dutch shareholders association VEB is threatening to take Philips (PHG.AS) to court over its handling of a global recall of respiratory machines, claiming it caused billions in losses by giving incorrect information to shareholders, Dutch paper FD reported on Monday, citing a letter the VEB sent to the company.

In the letter cited by FD, the VEB said Philips is responsible for around 16 billion euros of those losses, by giving false information about the machines affected.

It said reports by the U.S. Food and Drug Administration showed that people within the company knew of the problems years before users were informed.

Dutch shareholders threaten to sue Philips over recall, media report | Reuters