ResMed devices that use Adaptive Servo-Ventilation therapy

Consumers and health professionals are advised that, in addition to the affected devices listed below, two more ResMed devices are subject to this recall for product correction.

The additional models that are affected by this issue are:

• VPAP Tx (Product Code - 25103)
• S9 VPAP Tx (Product Code - 36030)

Recall for product correction - increased risk of death for patients with symptomatic chronic heart failure

14 May 2015

Consumers and health professionals are advised that ResMed, in consultation with the TGA, is undertaking a recall for product correction in relation to its devices that use Adaptive Servo-Ventilation (ASV) therapy (see below for list of affected devices).

ResMed devices that use ASV therapy are non-invasive flow generators (using a mask or similar device) that assist patients with various respiratory disorders. These devices are primarily used to treat central sleep apnoea in the patient's home.

Central sleep apnoea is a disorder in which a person's breathing repeatedly stops and starts during sleep. It occurs because the person's brain doesn't send proper signals to the muscles that control breathing. This condition is different from the more common obstructive sleep apnoea, in which you can't breathe normally because of upper airway obstruction.

AutoSet CS2

S9 VPAP Adapt

AirCurve 10 CS PaceWave

Recent clinical trial data has identified that there is a significant increased risk of death for patients using ASV therapy to treat moderate to severe predominant central sleep apnoea if they also have symptomatic chronic heart failure with reduced ejection fraction (see the Additional Information section below for further details).

ResMed is updating the Instructions for Use for this device to ensure it is no longer used for patients who are in the at-risk subgroup.

The following ResMed devices are affected by this issue:

• AutoSet CS (Product Code - 25005)
• AutoSet CS2 (Product Code - 26001)
• VPAP Adapt SV (Product Code - 26009)
• S9 VPAP Adapt (Product Code - 36367)
• VPAP Adapt (Product Code - 36377)
• AirCurve 10 CS PaceWave (Product Code - 37354)

Please note that ResMed's Continuous positive airway pressure (CPAP) and automatically-adjusting positive airway pressure (APAP) devices are not affected by this issue.

Information for consumers

ResMed has written to distributors providing further information about this issue, including instructions to notify health professionals who are treating patients who are using a ResMed device that uses ASV therapy.

The affected devices listed above should no longer be used by patients to treat moderate to severe predominant central sleep apnoea if they also have symptomatic chronic heart failure with reduced ejection fraction.

If you or someone you care for uses one of the affected devices, contact your health professional to see if using the device is still appropriate for you.

If it is determined that this treatment is no longer appropriate for you, contact the supplier of your device to arrange return.

If you have any questions or concerns about this issue, speak to your health professional or contact the supplier of your device. Alternatively, contact ResMed on 1800 647 259 or email SERVE-HFenquiries_ANZ@resmed.com.au.

Information for health professionals and health facilities

ResMed has written to distributors providing further information about this issue, including instructions to notify health professionals who are treating patients who are using a ResMed device that uses ASV therapy.

ResMed is updating the Instructions for Use for the affected devices listed above to contraindicate use in patients with symptomatic chronic heart failure (New York Heart Association functional classification 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%).

Health professionals need to identify and reassess all patients being treated with ASV therapy for symptomatic chronic heart failure. If signs or symptoms of heart failure are identified, an objective assessment of LVEF should be performed. Where appropriate, discuss with them immediate discontinuation of treatment.

Before commencing treatment with an affected device, patients should be assessed for signs and symptoms of heart failure. If any are identified, objective assessment of LVEF should be performed.

If you have any questions or concerns about this issue, contact the supplier of the device or contact ResMed on 1800 647 259 or email SERVE-HFenquiries_ANZ@resmed.com.au

Additional information

ResMed has published a statement regarding the Phase IV SERVE-HF Study, which includes a link to a Frequently Asked Questions webpage.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.