| TGA Action ID |
RC-2025-RN-00657-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
corpuls3 and corpuls3 Touch
Product Code: CP-4301 & CP-04302 |
| ARTG Number |
192745 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The IFU has been updated to emphasise the critical importance of verifying the results of the daily tests prior to use. Specific guidance has been added on the necessary user actions to be taken in the event of a failed test, including device replacement procedures and contact details for technical support.
The updates include the following:
- Importance of Daily Test Execution and Appropriate Response to identified defects:
· Failure to perform appropriate checks may result in undetected device readiness problems which may compromise emergency response effectiveness.
· It has been observed during post-market surveillance activities that the daily test is not always being consistently performed or reviewed by users as per the recommended procedure.
- Manual Electrode Type Selection in Case of Automatic Detection Failure:
· In rare cases, the device may not automatically detect the connected defibrillation electrode type. This behaviour is not indicative of a device malfunction, and appropriate functionality can be maintained through manual user selection of the electrode type.
These updates are included in the latest IFU revision: “ENG - Version 4.4 – P/N 04130.en” / Chapter 10.2. |
| Instructions for Customers/Users |
- An updated IFU and supplementary training materials are being issued to enhance user awareness and ensure proper device operation in all clinical scenarios, to maintain highest standard of patient safety.
- To support correct and consistent use in clinical scenarios, expanded guidance has been included in the IFU revision. The supplementary materials include:
· Explain the underlying system behaviour in the event of automatic detection failure,
· Guide users through the manual selection process step-by-step.
This action has been closed out on 18/11/2025. |
| Action Commencement Date |
28/07/2025 |
| Responsible Entity |
|
| Contact Information |
1300 388 423 - Device Technologies Australia Customer service |