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, Inc. Tec 6 Plus, Tec 820, and Tec 850 Vaporizers [HKMD No.: 190043, 241146].
According to the TGA, the manufacturer recently became aware of a manufacturing problem with certain Tec 6 Plus and Tec 800 series vaporizers. It was discovered that these vaporizers can deliver less anaesthetic agent than the vaporizer dial setting. If the vaporizer is not used in conjunction with an anaesthetic agent monitor, this can lead to insufficient anaesthetic effect, potentially causing patient movement during surgery and/or intraoperative awareness.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-01079-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 December 2024