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 Healthcare Finland Oy F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors [Product code: SUT; Reference number: 5861293; GTIN: 00195278524089] [HKMD No.: 190178].
According to the TGA, the manufacturer is informing of potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors. This interruption may occur if the F2-01 Frame is powered on continuously for more than approximately 120 days. As a result, parameter data from inserted E-modules will stop displaying or will be displayed intermittently. If this situation were to occur, it could cause a partial loss of monitoring potentially causing a delay in treatment.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00788-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 Sep 2023