Critical Consumer Safety Adaptive Servo-Ventilation (ASV) Alert

 

Servo-Ventilation

 

In a recent statement alert from Resmed, all  NYHA 2-4* users of Adaptive Servo-Ventilation (ASV) should NOT use said devices. A critical safety concern (from an SERVE-HF clinical study) has prompted this announcement to alert all ASV device distributors to alert existing clients and potential clients.

 

The primary risk of ASV units identifies that patients with symptomatic chronic heart failure (NYHA 2-4). This type of chronic heart failure involves reduced left ventricular ejection fraction as associated with predominant central sleep apnea (AHI worth more than 15/hour) may face being a fatality.

 

There are ResMed Devices that may exacerbate this kind of heart failure and sleep apnea, due to no technical fault or malfunction. These units are very high risk.
If you have Symptomatic Chronic Heart Failure with Reduced Ejection Fraction and moderate OSA, Please do NOT purchase, rent or use the following units:

 

• VPAP Adapt
• VPAP Adapt SV
• S9 VPAP Adapt
• S9 VPAP Tx
• VPAP Tx
• Lumis Tx
• AirCurve 10 ASV

 

For more information, call:
1.800.478.9010 within North America
1.858.836.5200 outside North America
Or go online to:
SERVE-HFfaqa.com
Contact ResMed Representative

 

*symptomatic chronic heart failure with reduced left ventricular ejection fraction  associated with predominant central sleep apnea (AHI worth more than 15/hour)

Questions?

Call 1.877.430.2727 for help.

Edited by Bill Bistak B Sc.,SEO/SEM Spc, CRT

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