| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01065-1 |
| Product Name/Description |
Rechargable Lithium Ion Battery used in Beneview T1 Patient Monitors
Multiple Battery Serial Numbers
ARTG Number:223384 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Mindray has identified the potential for overheating of the Rechargeable Lithium Ion battery used in Beneview T1 Patient Monitors. The initial failure mode and clinical assessment indicated that the problem may result in the battery overheating, smoke, and the possible melting of the monitor shell under extreme circumstances.
To date, there are no reports of patient injuries associated with this potential issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Pass this Notice to all within your organisation or to any organisation where the potentially affected device(s) have been transferred.
2. Stop using the Rechargeable Lithium Ion battery of Beneview T1 Patient Monitor. Mindray service representatives will contact users to replace the affected batteries.
3. Store the affected batteries properly as follows;
· Do not charge batteries.
· Prevent short circuiting of the batteries. For example, covering the two ends of the connector with insulating tape.
· Store the batteries at cool places(=21°C) away from combustibles.
· Store the batteries separately, do not mix, overlay or pile up them with other batteries.
4. Mindray Service Representatives will visit to collect and dispose of the batteries.
This action has been closed out on 15/01/2019 |
| Contact Information |
1800 793 011 - Mindray Customer Service |