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ResMed warning for ASV devices
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zonk Offline

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Machine: A10 AutoSet
Mask Type: Nasal mask
Mask Make & Model: Activa LT
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CPAP Pressure: 9/13
CPAP Software: ResScan

Other Comments: CPAP since Nov 2010

Sex: Male
Location: Australia

Post: #1
ResMed warning for ASV devices
[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
08-16-2015 05:29 PM
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zonk Offline

Advisory Members

Posts: 7,908
Joined: Feb 2012

Machine: A10 AutoSet
Mask Type: Nasal mask
Mask Make & Model: Activa LT
Humidifier: Integrated /ClimateLineAir
CPAP Pressure: 9/13
CPAP Software: ResScan

Other Comments: CPAP since Nov 2010

Sex: Male
Location: Australia

Post: #2
RE: ResMed warning for ASV devices
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
08-16-2015 05:51 PM
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storywizard Offline

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Posts: 350
Joined: Jul 2014

Machine: ResMed VPAP Adapt S9
Mask Type: Nasal pillows
Mask Make & Model: P10 taped to face
Humidifier: included with machine
CPAP Pressure: CPAP 11cm
CPAP Software: SleepyHead

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Sex: Male
Location: Vancouver, BC, Canada

Post: #3
RE: ResMed warning for ASV devices
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
08-16-2015 05:53 PM
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zonk Offline

Advisory Members

Posts: 7,908
Joined: Feb 2012

Machine: A10 AutoSet
Mask Type: Nasal mask
Mask Make & Model: Activa LT
Humidifier: Integrated /ClimateLineAir
CPAP Pressure: 9/13
CPAP Software: ResScan

Other Comments: CPAP since Nov 2010

Sex: Male
Location: Australia

Post: #4
RE: ResMed warning for ASV devices
(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
08-16-2015 05:57 PM
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storywizard Offline

Advisory Members

Posts: 350
Joined: Jul 2014

Machine: ResMed VPAP Adapt S9
Mask Type: Nasal pillows
Mask Make & Model: P10 taped to face
Humidifier: included with machine
CPAP Pressure: CPAP 11cm
CPAP Software: SleepyHead

Other Comments:

Sex: Male
Location: Vancouver, BC, Canada

Post: #5
RE: ResMed warning for ASV devices
(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
08-16-2015 05:58 PM
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zonk Offline

Advisory Members

Posts: 7,908
Joined: Feb 2012

Machine: A10 AutoSet
Mask Type: Nasal mask
Mask Make & Model: Activa LT
Humidifier: Integrated /ClimateLineAir
CPAP Pressure: 9/13
CPAP Software: ResScan

Other Comments: CPAP since Nov 2010

Sex: Male
Location: Australia

Post: #6
RE: ResMed warning for ASV devices
(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
08-16-2015 06:00 PM
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me50 Offline

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Posts: 2,559
Joined: Aug 2013

Machine: resmed S9 VPAP Auto
Mask Type: Nasal mask
Mask Make & Model: Wisp and Silicone Head gear
Humidifier: resmed H5i
CPAP Pressure: 18/8
CPAP Software: SleepyHead

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Sex: Undisclosed
Location: USA

Post: #7
RE: ResMed warning for ASV devices
(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.
08-16-2015 08:55 PM
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me50 Offline

Advisory Members

Posts: 2,559
Joined: Aug 2013

Machine: resmed S9 VPAP Auto
Mask Type: Nasal mask
Mask Make & Model: Wisp and Silicone Head gear
Humidifier: resmed H5i
CPAP Pressure: 18/8
CPAP Software: SleepyHead

Other Comments:

Sex: Undisclosed
Location: USA

Post: #8
RE: ResMed warning for ASV devices
(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.
08-16-2015 08:57 PM
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DeepBreathing Offline
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Posts: 2,296
Joined: Sep 2013

Machine: Resmed S9 VPAP Adapt
Mask Type: Full face mask
Mask Make & Model: F&P Simplus
Humidifier: Resmed H5i
CPAP Pressure: EPAP: 9 - 15 PS: 3 - 10
CPAP Software: ResScan SleepyHead

Other Comments:

Sex: Male
Location: Perth, Western Australia

Post: #9
RE: ResMed warning for ASV devices
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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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.
08-16-2015 09:40 PM
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zonk Offline

Advisory Members

Posts: 7,908
Joined: Feb 2012

Machine: A10 AutoSet
Mask Type: Nasal mask
Mask Make & Model: Activa LT
Humidifier: Integrated /ClimateLineAir
CPAP Pressure: 9/13
CPAP Software: ResScan

Other Comments: CPAP since Nov 2010

Sex: Male
Location: Australia

Post: #10
RE: ResMed warning for ASV devices
(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
08-16-2015 09:48 PM
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