ResMed Ltd—S8 Family Flow Generators

What are the defects?

The power supply connection in some devices manufactured before 15 May 2006 may be susceptible to fatigue, and present a remote risk of thermal damage external to the device.

What are the hazards?

Illness or mistreatment (Class II).

What should consumers do?

Customers will be contacted by their respective distributor or by ResMed during the next 12 months to replace affected units. There have been no reports of patient injury on patients as a result of this problem and patients may continue to safely use their flow generators until they receive a replacement unit. As with any electrical device, patients should make sure tht it is placed on a hard clean surface during use. Patients should discontinue use of the device if there are signs of any electrical failure. ResMed does not recommend using supplemental oxygen with the affected device until the device is replaced. Further information is available from the S8 Replacement Program Call Centre 1800 625 088.

Supplier
ResMed Ltd
Where the product was sold
Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.