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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BeneHeart D1 Automated External Defibrillator [HKMD number: 150304].
According to the TGA, the BeneHeart D1 can support MR60, MR61, MR62, MR63 electrode pads and some customers may purchase more than one model of electrode pads. When there are different models of electrode pads connected to the D1, different prompts for the connection of pads appear on the device. However, those different connection prompts might be confusing for the customers.
For further information, please visit: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00488-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 Jun 2024