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 Datex-Ohmeda Avance CS2 and Avance CS2 Pro anesthesia devices [HKMD No.: 120542].
According to TGA, the manufacturer advices of a potential battery issue can result in premature shutdown of the anesthesia device in situations where AC mains power is lost and back up emergency power is not available. The issue affects backup batteries in Avance CS2 and Avance CS.2 Pro anesthesia devices manufactured on or after 1 Apr 2019, and the recommended field replacement batteries distributed on or after 1 Apr 2019, for Avance CS2, Avance CS2 Pro, Avance, Amingo, and Aespire View can potentially fail earlier than their estimated life.
Anesthesia systems only operate on battery power in a rare event that AC mains power shuts off and there is no backup emergency power. If this situation is not identified and addressed by the attending clinician, the loss of ventilation may be life threatening.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-00683-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 May 2022