Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Shenzhen Mindray Bio-Medical Electronics Co., Ltd. A9 Anaesthesia System [Product codes: 0648B-PA00026, 0648B-PA00016, 0648B-PA00097, 0648B-PA00128, 0648B-PA00135] [HKMD number: 210096].

According to the TGA, two problems have been identified with certain serial numbers of A9 Anaesthesia systems.

• System may give a false alarm "Auto/Manual Switching Failure" when switching the Auto/Manual switch. When this occurs the actual ventilation mode has been successfully switched, and device ventilation is normal.
• When the anaesthetic concentration on the device interface is set, the device may not respond and continue to output the original set anaesthetic concentration. It was found that the problem occurred in Automatic Control Anaesthesia (ACA) mode. When the patient's respiratory rate exceeds 35bpm within 1 second and then immediately drops below 35bpm, there may be situations where the device status exits ACA mode, but the display interface remains in ACA mode, resulting in the problem. The device can still monitor and display the true anaesthetic concentration on the interface.

For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00801-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 Sep 2024