Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Respironics, Inc BiPAP A40 [Serial numbers: V2887246677A0, V288724698F57, V28872472285C, V288724777FF1, V28872479968F, V288724808886, V28872485DF2B, V28872492B24C, V28872495C6F3, V288724981D16, V288725010D13, V2887251114CB and V2887251771FD] [HKMD No.: 130292].
According to the TGA, the manufacturer has determined that certain devices were built with motor assemblies that could contain non-conforming plastic material. The patient may be exposed to the following hazards if the non-conforming material is present: i) Exposure to off-gassing not normally present creating a potential biosafety or toxicological hazard. ii) Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01118-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Aug 2022