| TGA Action ID |
RC-2026-RN-00021-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
BeneHeart C Series Automated External Defibrillator
Model: BeneHeart C2, BeneHeart C2 Fully Automatic, BeneHeart C1A, BeneHeart C1A Fully Automatic
Multiple serial numbers |
| ARTG Number |
166368 |
| Action Type |
Product Correction |
| Action Level |
Consumer |
| Hazard Classification |
Class II |
| Reason for the Action |
Mindray has updated the operator's manual of the Mindray BeneHeart C Series Automated External Defibrillator, to address two potential problems:
- When the equipment is configured with Wi-Fi/cellular turned on, it automatically sends self-test reports by default, which consume extra battery power. In some network configurations, this could lead to a shortened battery life.
- The device automatically checks that new electrode pads have been attached after use, before shutdown. If new electrode pads aren’t connected, the status light on the device will flash red. The manual has been updated to make this information clearer.
To date, no patient injuries have been reported. |
| Instructions for Customers/Users |
Customers are to:
- Review the new electronic manual supplied by Mindray Medical Australia.
- As outlined in the manual, if the on-screen battery symbol indicates battery power is low or almost depleted, replace the battery immediately.
- Contact Mindray to disable the automatic sending of self-test reports via Wi-Fi/cellular, if this function is not needed.
- Before turning off the equipment, plug in the pads connector of new electrode pads.
The Mindray BeneHeart C Series AED can be used as per routine practice.
This action has been closed out on 28/04/2026 |
| Action Commencement Date |
27/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 793 011 - Mindray Medical Australia |