| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00488-1 |
| Product Name/Description |
BeneHeart D1 Automated External Defibrillator
Multiiple serial numbers
ARTG's: 166368 & 323031 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
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.
To date, Mindray has not received any report of serious incidents such as death or serious injury due to the above problem.
A new version of BeneHeart D1 product manual has been released, which adds electrode pad connection differences and a more detailed AED procedure to optimise the potential problem mentioned above. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
A new version of BeneHeart D1 product manual will be released to affected customers, which adds electrode pad connection differences and a more detailed AED procedure to optimise the potential issue mentioned above.
Mindray Medical Australia will contact customers as soon as possible to provide the new version of the product manuals of the affected units.
Customers should alert others to the problem by passing the customer letter onto those that use the device. |
| Contact Information |
1800 793 011 - Mindray Medical Australia Pty Ltd |