| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00733-1 |
| Product Name/Description |
Corpatch Easy Electrodes for Defibrillation Devices
Corpatch Easy Pre-connected
Ref code: 05120.1v
DT ordering code: CP-5120.1, CP-05120.1
Expiry date: 2025-10-13 or earlier
Corpatch Easy Pediatric
Ref code: 05120.3
DT ordering code: CP-5120.3
Expiry date: 2025-10-13 or earlier
ARTG's 418372, 430898 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility of contact failure between the electrode cable connector and the defibrillator.
Note: These devices are used with the corpuls1, corpuls3, corpuls3 SLIM and corpuls AED defibrillators.
It was determined that the contacting process (crimping) of the coding element within the corpatch easy electrode connector was not stable enough, preventing the provision of information of the electrode presence and type to the defibrillator.
If the defibrillator does not recognise an electrode, the message “Connect therapy electrodes” is displayed on the defibrillator monitor.
The manufacturer incorporated a design change and improvement in the manufacturing process in production from November 2022. Current batches are not affected by this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should:
1. Read and understand the contents of the customer letter.
2. Always have a replacement corpatch easy electrode available when using the corpuls1 and corpuls3.
3. If "Connect therapy electrodes" appears after connecting the electrode to the defibrillator, withdraw the affected electrode and use a replacement electrode immediately.
4. If customers have electrodes experiencing this problem they will be provided replacements. |
| Contact Information |
0418 624 428 - Sonia Hagel Product Manager |