Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips Respironics Sleep & Respiratory Care Devices [BiPAP A40; DreamStation; BiPAP A30; BiPAP Auto System One 60 Series; BiPAP AVAPS C Series; BiPAP A40 Pro; BiPAP A40 EFL (ARTG); Trilogy Evo, REMstar; SIMPLYGO and Elegance devices] [HKMD No.: multiple including 130292].
According to the TGA, the manufacturer have identified some sleep and respiratory care devices were supplied with a IEC52 (H02) power cord “light duty cord” instead of an IEC53 (H05) power cord “ordinary duty cord”.
The light duty cord will successfully provide power to the affected devices.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00980-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 Nov 2022