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 GE Medical Systems information Technologies All CARESCAPE Central Station V2 units [GTIN: 00840682109666 and 00840682109604] [HKMD No.:160431].
According to TGA, the manufacturer advises that the CARESCAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Patient monitoring at the bedside is not affected. Loss of monitoring can result in delayed response to a change in patient clinical condition. According to the manufacturer, there have been no injuries reported as a result of this issue.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00721-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 May 2022