The Australia Therapeutic Goods Administration (TGA), has issued a medical device safety alert concerning Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter [Product Codes: AG-AS3000-AU and AG-AP1040-AU], manufactured by Covidien Ltd.
The manufacturer has been notified by Aerogen Ltd. that there is a potential hazard with certain FRIWOAC mains power adaptors used with some of their Nebuliser Systems as supplied with the Aerogen Pro and Aerogen Solo nebuliser systems manufactured during the period of week 50/2013 and week 23/2014. The power adapter could potentially fail, whereby the plastic screw pillars can break and dislodge from the body and the adapter cover can open. If the failure was to occur during use then the internal electrical components of the mains power adapter would become exposed to the user and therefore there is a potential risk of electrical shock.
The manufacturer is contacting the hospitals and replacement adapters will be provided. The manufacturer is further requesting the customers to destroy the affected adapters per local disposal processes, when replacement AC mains power adapters are received.
For details, please refer to the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-01038-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Sep 2014