Phillips CPAP and BiPAP Recall - FAA sleep apnea compliance?

atbroome

atbroome

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The millions of v1 Phillips DreamStation machines have been recalled due to possible disintegration of PE-PUR foam used for sound deadening. Leading to a bunch of potential problems including cancer.

Phillips has recommended to stop usage immediately unless your sleep doc says you are more at risk to stop. If your sleep doc tells you it is a bigger risk to keep using the machine until Phillips addresses rather than stop, what is the FAA going to say when your usage hours are below FAA requirements?

https://www.philips.com/a-w/about/n...rtain-sleep-and-respiratory-care-devices.html
 
Looks like someone in that situation will either have to buy a new one now, or stop using the existing one and send it in for repair whenever they are able to get clearance on the repair process to start taking them. That website doesn't give an anticipated date of when they can begin taking machines in for repair.

It's not uncommon for someone to get a new CPAP. Turn in the report from your old one, turn in the report from your new one:

Then, and here's where I don't know the official answer, maybe add a letter explaining the gap.

FAA says they want annual documentation that 75% of sleep periods average >=6hrs. 75% of 365 is 274 days, so you could have about 90 days non-compliance. I don't know if they would raise an eyebrow if they saw that all in one chunk or not.

https://www.faa.gov/about/office_or...me/guide/special_iss/all_classes/sleep_apnea/

Now I need to see if mine is in that recall.
 
Spoke to my Doctor. His advice is for anyone with mild sleep apnea to stop using, while those with moderate to severe should keep using. My guess (and my guess only) is that will apply to just about every v1 machine out there and Phillips has a very big (read:expensive) mess on their hands. And it will get worse if anyone can tie a new chronic condition to using the device.
 
I'm guessing that mine is affected, too. Welp ... if it is I might just move on from Philips.
 
Here's a FAQ from Philips with a little more background:

https://www.philips.com/c-dam/b2bhc...ments/philips-recall-faqs-for-dme-hcp.pdf.pdf

Looks like a whole lot of their entire product line is affected. The soundproofing foam breaks down more quickly when the device is cleaned with ozone or UV cleaning methods, and in a high heat and humidity environment (the ambient environment, not the heat and humidity the device generates while running.)

My guess is: Since Philips, several times in that notice, said CPAPs should be replaced every 5 years and they also mentioned warranty periods, is that most of us will have to buy a new one or be moved to the end of the line for repairs.

Good times.
 
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Spoke with my DME vendor, they’re simply taking names of those who call in. So far they have no plans yet for replacement, loaners, or repairs. I opted to buy a second machine as I didn’t want to wait for Philips and/or the DME to drag their feet. It’s taken me a while to get used to CPAP and it’s worked wonders for me. It’s also been a journey to get logging for my initial class 3 SI I didn’t want this to derail my progress.
 
It’s pretty clear Phillips doesn’t have much of a plan yet
 
Checkout_my_Six said:
You should always have a backup....lol :D
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I have two backups (older machines), but they don't have the recording abilities I need for my Class III. If I jump over to Basic Med then I don't even need to worry about that anymore, either. But my older machines also don't have the auto pressure capability.
 
Matthew said:
I have two backups (older machines), but they don't have the recording abilities I need for my Class III. If I jump over to Basic Med then I don't even need to worry about that anymore, either. But my older machines also don't have the auto pressure capability.
Click to expand...
The Resmed is setable....in clinical mode. I monitor my wife’s unit....;)
 
Checkout_my_Six said:
The Resmed is setable....in clinical mode.
Click to expand...
I can get into clinician mode on all 3 of my machines (the two retired, and the daily driver) but only my current one can be set to auto range. The other two are fixed, so I would have to set them to match whatever the current one reaches in the 90th percentile or whatever.
 
So I emailed my AME and asked the question about this recall and the repercussions - He talked the FAA:
His response:
Thanks for the e-mail.

I called the FAA and spoke to the doctor there.

He basically said that there are 2 issues.

First, your question. He said that if you include the documentation from the manufacturer about the recall and your MD sleep apnea status report mentions that the machine was recalled for patient safety reasons, the FAA will not be concerned about any gaps in the compliance chip print-out.

The second issue is the one you didn't ask about. Since you have a disqualifying condition (OSA) which is not being treated while you are off the CPAP, by FAR 14 CFR 61.53 - operation of an aircraft during medical deficiency - he said you cannot fly as pilot in command until you are back on the CPAP.

The FAA doctor's suggestion is that you try to get a loaner machine until yours is back or replace yours with a machine from a different manufacturer. Anyway, you are grounded until you get back on CPAP.

Hope this helps.​
 
Matthew said:
I ordered mine yesterday.
Click to expand...

I left one on an international Delta flight overhead bin and United Healthcare bought me a new one. I got it back from Delta about two months later and United didn't care. I now have two units...the Resmed Airsense 10 has been rock solid for me...
 
For anyone switching to Resmed, fyi it's very easy to get the FAA-required reports. MyAir automatically pulls data from newer machines through cellular once you register. Just click on "History," then hit the "Report" button in the top right corner. Takes 30 seconds and gives you everything the FAA needs. No dealing with an SD card, DMES, or OSCAR or any other software.
 
Kelvin said:
I left one on an international Delta flight overhead bin and United Healthcare bought me a new one. I got it back from Delta about two months later and United didn't care. I now have two units...the Resmed Airsense 10 has been rock solid for me...
Click to expand...

Welp...

I spoke too soon. I talked to the owner of the supply place (I pay out of pocket and avoid the ins co), and he said they had them in stock. By the time they processed my order they were out. He said he has another 20 on the way,
 
Matthew said:
Welp...

I spoke too soon. I talked to the owner of the supply place (I pay out of pocket and avoid the ins co), and he said they had them in stock. By the time they processed my order they were out. He said he has another 20 on the way,
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Sad part is they’re not cheap. I just got one and it was darn near $800 private pay. I’m still going to see what happens with my Philips that was paid for by insurance as the supplies are paid for by insurance. The new one I have isn’t covered nor are the supplies.
 
Beaker’s Flyin said:
Sad part is they’re not cheap. I just got one and it was darn near $800 private pay. I’m still going to see what happens with my Philips that was paid for by insurance as the supplies are paid for by insurance. The new one I have isn’t covered nor are the supplies.
Click to expand...
Different model capabilities can really affect the cost.
 
If your car breaks, you get an alternate set of wheels to keep getting to work.
If your CPAP machine breaks/is unsafe, you get a different one and keep going.
 
Matthew said:
The soundproofing foam breaks down more quickly when the device is cleaned with ozone or UV cleaning methods, and in a high heat and humidity environment (the ambient environment, not the heat and humidity the device generates while running.)
Click to expand...

What if one operated their dreamstation in a cool environment and had never cleaned the thing, just replaced hoses, filters, and parts periodically? asking for a friend :D
 
schmookeeg said:
What if one operated their dreamstation in a cool environment and had never cleaned the thing, just replaced hoses, filters, and parts periodically? asking for a friend :D
Click to expand...
That would be what I've been doing with it. I dunno - I don't think I have enough info on what they've found with these things. Maybe they don't know either.
 
If you are a DIY'r there are videos online to fix your machine and remove the foam. Did it for my friend's machine. My wife is quite happy.....just take care with the ribbon cable for the front LCD panel....it's very fragile.
 
I was "lucky", I fronted the cash for a Resmed from my DME. I then returned the Phillips machine and was reimbursed for the cost of the Resmed and it is now covered by insurance for supplies. It wasn't as complicated as it sounds..
 
If this duplicates an earlier note, I apologize. Technology and I don’t always get along.

I just found my CPAP is on the recall list, but I think I’ll keep using it as I’ve never used any of the referenced cleaning solutions. It’s now about 8 years old and I was not aware (as referenced above) there was a TBO so to speak of 5 years. After double-checking with my insurance, my plan, unless someone offers a better way, is to ask my pulmonary doc if he can just order me up a new one. I do have a spare here he ordered for my wife who doesn’t use it. I suspect I could reprogram that one to my specs without much trouble.

I could just quit using my existing one until a new one shows, but I don’t want the hassle of explaining any large gap in the required report.

And, of course, I make this discovery 10 days before going to see my AME for my annual check on the status of all my SI issues. Heck, maybe he has some ideas. As Roseanne Roseannadanna would say: It’s always something.
 
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