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[CPAP] Oscar, data formats, DS2, Airsense refurbished
#11
RE: Oscar, data formats, DS2, Airsense refurbished
I was intrigued by what you guys told me about DS1 able to produce Oscar-compatible data.
As I have not returned my DS1 yet, I attacked the problem of removing the foam without breaking the internal plastic case.
It worked!

https://imgur.com/a/KoiXvdv

Now I am tired, but I'll see if I can collect some data in the next few days

Thanks a lot for all the support so far!

Fillmore
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#12
RE: Oscar, data formats, DS2, Airsense refurbished
Multiple attempts to contact the FDA failed. Does anyone have a suggestion of how I can contact their consumer complaint people?

The answering machine returns an email address that is not active  Oh-jeez
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#13
RE: Oscar, data formats, DS2, Airsense refurbished
I did a search and found the following:
FDA.gov: How to Report Product Problems and Complaints to the FDA

FDA.gov: How do I report non-emergencies about medical products: medicines, medical devices, blood products, biologics, special nutritionals?

Form FDA 3500B - Voluntary Reporting Form for Consumers (pdf)

I hope this may help.
Crimson Nape
Apnea Board Moderator
www.ApneaBoard.com
___________________________________
Useful Links -or- When All Else Fails:
The Guide to Understanding OSCAR
OSCAR Chart Organization
Attaching Images and Files on Apnea Board
Apnea Helpful Tips

INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#14
RE: Oscar, data formats, DS2, Airsense refurbished
Saw that. Tried to call 410-779-5713 several times. Only getting an answering machine that advises to either leave a message (I did yesterday, so far no response) or send an email to orabltccc@fda-hhs.gov (email address does not exist).  Dont-know
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#15
RE: Oscar, data formats, DS2, Airsense refurbished
How about filling out the form?

In the form, it has the following:

How can I contact the FDA if I have questions?
Crimson Nape
Apnea Board Moderator
www.ApneaBoard.com
___________________________________
Useful Links -or- When All Else Fails:
The Guide to Understanding OSCAR
OSCAR Chart Organization
Attaching Images and Files on Apnea Board
Apnea Helpful Tips

INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#16
RE: Oscar, data formats, DS2, Airsense refurbished
(10-22-2021, 12:21 PM)Crimson Nape Wrote: How about filling out the form?

My idea was that I would talk to a human and get some basic advice on whether I am talking to the right people and how to maximize the chance that the FDA will seriously look at my report, but maybe you are right, I should simply go with the form.

Thanks
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#17
RE: Oscar, data formats, DS2, Airsense refurbished
(10-22-2021, 12:21 PM)Crimson Nape Wrote: How about filling out the form?

In the form, it has the following:

How can I contact the FDA if I have questions?

Ok, thank you for the encouragement, Nape. I called the FDA at the 800 number you provided and (after they transferred my call internally) Bill told me that this does not seem like an issue with the Medical equipment itself, but rather something that is probably that falls under HIPAA and my rights connected to HIPAA. Without prejudice to my choice to still file an FDA form, Bill advised that I do my research and see which agency may assist with HIPAA (CDC? HHS?) and try to contact them.

Probably a good idea, but before I do that, any comments from members of this honorable forum?

Thank you, guys.
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#18
RE: Oscar, data formats, DS2, Airsense refurbished
For good measure, I also filed the FDA form that Crimson recommended. Wish me luck.
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