Phillips / Philips Respironics recent recall notice discussion thread

[Ozzorag]

I'm aware no one can give a definitive answer, but my wife is sick of hearing me obsess over this so I am just venting here in case anyone has some good feedback .

I have a DS1 and was a new CPAP user when I got it in Dec 2020, I didn't know better so I got a so-clean and used it for about a week early on and hated the way it made everything smell like chlorine, so I ditched it. I'd be surprised if I used it 10 times total, probably more like 6 or 7 if I had to guess. Anyone think that's enough to accelerate the breakdown of the foam in any appreciable manner, I'd assume its more and issue with people who used it nightly for an extended period, but haven't been able to confirm that anywhere.

I have noticed some very mild heaviness in my breathing and post nasal drip that makes me cough and my voice a bit horse in the morning for the past couple months but figured it was allergies, nothing serious just annoying. Either way, I'm not gonna use the machine anymore until I get the new ResMed AS 11. Hopefully these symptoms clear up.

I'm attaching a pic of the inner casing, everything looked clean, the motor too when I took that out without any black fragments, but I know that alone doesn't mean the breakdown hasn't started and its hard to tell for sure still being enclosed. I'll probably end up just cracking the plastic open to know for sure because its killing me not knowing how bad it is, but figured I'd get some opinions here first before destroying it. Aside from the very brief so clean usage, it was never in a hot or humid environment so I'm hoping its not too bad.

I'm, pretty late to the party here, I just got my letter on July 28, annoying I could have stopped using it a month or more longer if I was notified sooner. I have very mild apnea with an AHI of 6.5, so I would have happily skipped treatment for a few weeks. Thanks all

[BrianD]

For those who had relatively new machines under warranty, many may end up with repaired machines with no warranty. I find this completely unacceptable if it's the case. Further, by the time they get around to handling the recall, many will be already acclimated to Resmed machines and have no desire to deal with going back to Respironics, in my opinion. Compounding the previous with the obfustication of the data in their newest machines I can't imagine people racing to get back to a new Respironics machine. I wouldn't buy any machine I couldn't see my data daily with all the detail in graph form, this will also impede doctors offices who don't deal with each vendors systems and were happy with me bringing in my data detail and going over it with me and having real discussions with current relevant data I was bringing forward.

[ILoveFlowers]

It’s been said that Philips took a new boxed unit and tested it for the gassing off of the foam and the findings were positive.

Thanks, I did hear that in the time since the first information came out. Gives you pause. Do you have a source where I could read about this test?

[JLROhio]

It’s been said that Philips took a new boxed unit and tested it for the gassing off of the foam and the findings were positive.

Thanks, I did hear that in the time since the first information came out. Gives you pause. Do you have a source where I could read about this test?

I don't have a direct source...but here is the report from Philips that they provided to Doctors where they discuss VOC's and off-gassing.
https://www.philips.com/c-dam/b2bhc/mas ... viders.pdf

I believe the Australian guy, who does YouTube video's on the subject, made specific mention about new out of the box units off-gassing.
This was about a month ago - I think this is the video ----> https://www.youtube.com/watch?v=kFxtA3y1ucQ

EDIT'd: He says it at the 5:00 min mark in the above video about off-the-shelf

[ChicagoGranny]

It’s been said that Philips took a new boxed unit and tested it for the gassing off of the foam and the findings were positive.

Thanks, I did hear that in the time since the first information came out. Gives you pause. Do you have a source where I could read about this test?

------------------->

Volatile organic chemicals of concern (Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) are not detectable 24 hours after the first ‘out of box’ use of the device.
Levels of diethylene glycol detected were within an acceptable margin of safety.
The degradation by-products Toluene Diamine and Toluene Diisocyanate are classified by IARC as Group 2B carcinogens. This category is used for chemicals where there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.

https://www.gov.uk/drug-device-alerts/n ... slash-mhra

[JLROhio]

Volatile organic chemicals of concern (Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) are not detectable 24 hours after the first ‘out of box’ use of the device.
Levels of diethylene glycol detected were within an acceptable margin of safety.
The degradation by-products Toluene Diamine and Toluene Diisocyanate are classified by IARC as Group 2B carcinogens. This category is used for chemicals where there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.

https://www.gov.uk/drug-device-alerts/n ... slash-mhra

Note: if you read the earning call thread I started...they (Philips) discussed the UK Gov't study...but even they indicated, while it sounds good...they are still going out and doing multiple lab testing of their own, with multiple labs, to determine ongoing issues with the the VOC's, the TDI & TDA, and the diethylene glycol.

Bottom Line, even Philips is not doing a victory lap yet on the UK report...there's more to follow, and follow-up on.

[don505]

Just received a Weinman / Lowenstein Prisma 20A auto CPAP machine to replace my DS1 toxic foam unit. I used the same settings as the retired Philips DS1 but now I am battling with aerophagia. I didn't have this issue with the DS1. Although given the choice between VOC's or aerophagia I choose the latter. In any case I received a letter from Philips Healthcare (Australian HQ) in late June 2021 advising that "Patients are advised to not cease use of these devices without speaking to their physician or care provider."
Philips Australia have not indicated what the fix will be but there is a strong hint that existing machines will be repaired and not replaced.

[Grumpy48]

Philips Australia have not indicated what the fix will be but there is a strong hint that existing machines will be repaired and not replaced.

If Philips Australia (or any of the worldwide Philips divisions) opts to repair existing machines, this is very good reason not to attempt removal of the foam. The removal of the foam would be certain evidence of disassembly of the unit which may preclude the repair of the device due to the user potentially damaging something internally. Years ago when I was doing occasional repair work for an electronic shop, if there was any indication that the customer attempted a 'fix' or modification, we either wouldn't accept the repair or if we did, the repair ticket would state no warranty on the repair due to evidence customer tampering. Maybe Philips will play nice and ignore modified units .

[ChicagoGranny]

Maybe Philips will play nice and ignore modified units .

I'm guessing they will ignore tampering by users. Not because of playing nice; because of making their liability issues worse.

[Hutch]

Anyone have any idea how long before they start actually doing something besides taking our info.. I have one that I use inside/bedroom and while we have high humidity here in So. Louisiana I am not scared of using it, the other machine I keep in my truck where during the summer time parked the temps can reach over 100 degrees inside, that would degrade the foam for sure, I do not use that machine but once a year or even less now, it is for if I get stuck out on the road sleeping in a motel someplace.. I am seriously considering buying another machine if this process is going to continue to take forever..

[Pugsy]

Anyone have any idea how long before they start actually doing something besides taking our info..

No idea....final FDA approval for their (Phillips) "plan" hasn't even happened yet....and we all know how speedy the FDA isn't.

I am seriously considering buying another machine if this process is going to continue to take forever..

Depends on your idea of "forever" I guess. Plan for the worst and hope for the best.
Even once they actually start implementing their "plan" (after FDA gets around to approving it" there is zero way to know where you will be in the very big list of people who need to have their machine either fixed or replaced.

Rumor control said that the machines that treat more critical issues would likely be slated to be first in line though.
Those high end machines that treat special respiratory issues that are classified as ventilators perhaps.
Regular cpap/apap models I suspect will be way down on the priority list.

[Dog Slobber]

Anyone have any idea how long before they start actually doing something besides taking our info..

According to the Philips Earning Call, The CEO estimated about 8 weeks for FDA approval based on past experience. The "806 applications" were filed in June, so assuming the 8 week approvals estimate is accurate then the replacements might start anytime now,

...

We are fully prepared to start with comprehensive repair and replacement actions for the affected units. We are still in discussions with the relevant regulatory authorities to obtain authorization to start deploying the repair kits and replacement devices that we are producing. For example, we have submitted the relevant applications to the FDA in June. We've already increased the overall production of DreamStation 1 and DreamStation 2 devices as well as repair kits from 30,000 units per week to 55,000 units per week as of the start of the third quarter. And we expect to reach 80,000 units per week in the fourth quarter, which underpins our expectation to address all devices in scope within 12 months of regulatory approval

...

I cannot exactly predict when we get approval. I can only say that FDA is on top of it, and working very diligently. Let's say experience would show that kind of an eight-week approximate throughput time on an 806 could be expected. But that's out of prior experience, not necessarily related to this case.

[JohnO]

Hello to all my CPAPTalk friends! I haven't been here much lately, as my therapy is working well, but popped into say I received this recall notice via UPS Letter yesterday. Surprised it has been almost two months since the first notices went out.

Another 10 months and it'd be time for a new machine anyway. We shall see what happens.

John

[JLROhio]

Hello to all my CPAPTalk friends! I haven't been here much lately, as my therapy is working well, but popped into say I received this recall notice via UPS Letter yesterday. Surprised it has been almost two months since the first notices went out.

Another 10 months and it'd be time for a new machine anyway. We shall see what happens.

John

Who sent you the letter? Philips, your DME, Medicare, the VA ???

On another point, I have now noticed Attorney commercials on TV now about the recall. Those attorneys are trying to sign up as many as they can, so that they can lead the hopeful class-action lawsuit they hope to file...and settle for millions (while everyone else will get 6 months worth of Philips masks).

[ChicagoGranny]

while everyone else will get 6 months worth of Philips masks

More like a coupon for one free headgear.