| TGA Action ID |
RC-2026-RN-00393-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BeneHeart D1 Automated External Defibrillator (AED)
Model : BeneHeart D1 |
| ARTG Number |
166368 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
To help users better understand the procedure for switching patient types on the Mindray BeneHeart D1 Automated External Defibrillator (AED), Mindray has updated the Operator's Manual with refined guidance.
When the device is set to paediatric mode and used for adult patients, there is a risk of ineffective defibrillation.
This Operator’s Manual revision only adds supplementary information. No changes have been made to the product itself or its operational procedures. |
| Instructions for Customers/Users |
Mindray Medical Australia and/or authorised distributors will supply customers with the updated Operator’s Manual.
Customers/users are to:
1. Familiarise themselves with the updated Operator's Manual, in particular section 5.4.
2. As outlined in the manual, when the indicated patient type is different to the patient, manually change the patient type.
The Mindray BeneHeart D1 can be used as per routine practice. |
| Action Commencement Date |
28/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 793 011 - Mindray Medical |