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ResMed warning for ASV devices
#1
[Image: logo.png]
Recall for product correction - increased risk of death for patients with symptomatic chronic heart failure
https://www.tga.gov.au/alert/resmed-devi...on-therapy


U.S. Food and Drug Administration (FDA) - Protecting and Promoting Your Health
Philips Response To ResMed Update On Phase IV SERVE-HF Study Of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea And Chronic Heart Failure

http://www.fda.gov/Safety/Recalls/ucm450858.htm
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#2
More information ...

ResMed Provides Update on Phase III SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea and Chronic Heart Failure http://www.prnewswire.com/news-releases/...82445.html

ResMed ASV Devices: Recall for Product Correction
FAQs http://www.airliquidehealthcare.com.au/f...180730.pdf
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#3
This has been discussed in this thread: http://www.apneaboard.com/forums/Thread-...ght=safety

and this one: http://www.apneaboard.com/forums/Thread-...ss+release

Thought this was done with for now...??

Storywizard
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#4
(08-16-2015, 05:53 PM)storywizard Wrote: This has been discussed in this thread: http://www.apneaboard.com/forums/Thread-...ght=safety

and this one: http://www.apneaboard.com/forums/Thread-...ss+release

Thought this was done with for now...??

Storywizard
Error 404 Page Not Found, when clicked on either threads

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#5
(08-16-2015, 05:57 PM)zonk Wrote:
(08-16-2015, 05:53 PM)storywizard Wrote: This has been discussed in this thread: http://www.apneaboard.com/forums/Thread-...ght=safety

and this one: http://www.apneaboard.com/forums/Thread-...ss+release

Thought this was done with for now...??

Storywizard
Error 404 Page Not Found, when clicked on either threads

Oh well...carry on then...:-)

Storywizard
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#6
(08-16-2015, 05:58 PM)storywizard Wrote:
(08-16-2015, 05:57 PM)zonk Wrote:
(08-16-2015, 05:53 PM)storywizard Wrote: This has been discussed in this thread: http://www.apneaboard.com/forums/Thread-...ght=safety

and this one: http://www.apneaboard.com/forums/Thread-...ss+release

Thought this was done with for now...??

Storywizard
Error 404 Page Not Found, when clicked on either threads

Oh well...carry on then...:-)

Storywizard
I don't get it ... carry on with what
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#7
(08-16-2015, 05:29 PM)zonk Wrote: [Image: logo.png]
Recall for product correction - increased risk of death for patients with symptomatic chronic heart failure
https://www.tga.gov.au/alert/resmed-devi...on-therapy


U.S. Food and Drug Administration (FDA) - Protecting and Promoting Your Health
Philips Response To ResMed Update On Phase IV SERVE-HF Study Of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea And Chronic Heart Failure

http://www.fda.gov/Safety/Recalls/ucm450858.htm

I haven't heard of the S9 VPAP Tx before

Thanks for the info Zonk.
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#8
(08-16-2015, 05:53 PM)storywizard Wrote: This has been discussed in this thread: http://www.apneaboard.com/forums/Thread-...ght=safety

and this one: http://www.apneaboard.com/forums/Thread-...ss+release

Thought this was done with for now...??

Storywizard

This is the first I heard of this and with new people joining all the time, never hurts to repeat something this critical, especially since the 2 threads you posted provide an error message.

Better safe than sorry.
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#9
It's important to note that the only "modification" being made is a label and an update to the manual. The machines themselves are not changed in any way. This affects only patients using ASV with chronic heart failure and reduced ejection fraction < 45%. Resmed have initiated a recall, but I haven't heard if other manufacturers have responded?

It's also interesting to note my supplier hasn't bothered to contact me about this recall - pretty slack, I think.
DeepBreathing
Apnea Board Moderator
www.ApneaBoard.com


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#10
(08-16-2015, 06:00 PM)zonk Wrote:
(08-16-2015, 05:58 PM)storywizard Wrote:
(08-16-2015, 05:57 PM)zonk Wrote: Error 404 Page Not Found, when clicked on either threads

Oh well...carry on then...:-)

Storywizard
I don't get it ... carry on with what
Now I can see your concern
In hindsight, things might be done differently
Admin and Mods can always use the delete button

As for topics been discussed before, most of stuff we spend our time talking about, has been talked about many times over in many different threads. Always get some new insights in new threads, yet the subject matter is not that new


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