ResMed Ltd—S8 Family Flow Generators

PRA number

2007/9219

Published date

Product description

Model name: S8 Lightweight. Product code: 33032. ARTG no: 117912. Model name: S8 Autoscore - ANZ. Product code: 33033. ARTG no: 117912. Model name: S8 AutoSet Spirit - ANZ. Product code: 33126. ARTG no: 119243. Serial numbers are in the following ranges: 20040285613 - 20060294694. 20060326736 - 20060327794.

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.

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