| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00801-1 |
| Product Name/Description |
A9 Anaesthesia System
Product codes: 0648B-PA00026, 0648B-PA00016, 0648B-PA00097, 0648B-PA00128, 0648B-PA00135
Multiple serial numbers
ARTG 158607
(Mindray Medical Australia Pty Ltd - Anaesthesia system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Two problems have been identified with certain serial numbers of A9 Anaesthesia systems.
#1: 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.
#2: 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.
No patient injuries have been associated with either problem. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The Mindray service team will contact customers to upgrade the software to correct the two problems.
In the interim customers can continue to use the device by following the below:
1. If there is an "Auto/Manual switching failure" alarm, re-start the A9 or perform a self-test to eliminate the alarm.
2. If changing the anaesthetic concentration setting in ACA mode is unsuccessful, it can be resolved by manually exiting. |
| Contact Information |
1800 793 011 - Mindray Customer Service |