Philips devices that use auto servo ventilation therapy

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

17 June 2015

Consumers and health professionals are advised that Philips, in consultation with the TGA, is undertaking a recall for product correction in relation to its devices that use auto servo ventilation (ASV) therapy (see below for list of affected devices).

Philips 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.

The following Philips devices which have been supplied in Australia are affected by this issue:

  • BiPAP autoSV Advanced System One (60 Series) [pictured below]
    image of BiPAP autoSV Advanced System One (60 Series)
  • BiPAP autoSV Advanced System One (50 Series)
  • BiPAP autoSV Advanced with SmartCard (SV3) [pictured below]
    image of BiPAP autoSV Advanced with SmartCard (SV3) [pictured below]
  • BiPAP autoSV with SmartCard (SV2)
  • OmniLab Advanced + [pictured below]
    OmniLab Advanced + [pictured below]
  • OmniLab Advanced
  • BiPAP autoSV

Philips' recall action is based on recent clinical trial data from a study undertaken by ResMed that has identified 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.

Philips is evaluating the data provided by ResMed to see what impact it may have on patients using its ASV devices. In the meantime, Philips strongly recommends that patients currently receiving treatment with these devices be evaluated to see if they fall within the at-risk population and, if so, a discussion about whether to discontinue ASV therapy should occur. Do not initiate ASV therapy in new patients until they have been assessed to ensure that they do not fall within the at-risk population.

Information for consumers

The affected devices listed above should not 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 you have any questions or concerns about this issue, speak to your health professional or contact the supplier of your device. Alternatively, contact Philips on 1300 766 488.

Information for health professionals and health facilities

Philips is evaluating the data relating to the identified safety risk to determine appropriate action.

In the meantime, as a precautionary measure, it may be appropriate to discontinue treatment with the devices listed above if a patient being treated for moderate to severe predominant central sleep apnoea has symptomatic chronic heart failure (New York Heart Association functional classification 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%).

Health professionals should identify and evaluate current patients being treated with ASV therapy to determine if they fall within the at-risk population. 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. Do not initiate ASV therapy in new patients if they fall within the at-risk population.

If you have any questions or concerns about this issue, contact the supplier of the device or contact Philips on 1300 766 488.

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.

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