| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2021-RN-02364-1 |
| Product Name/Description |
Defigard Touch 7
All software version less than or equal to V08B20
Multiple serial numbers
ARTG 107242
(Intermed Medical Pty Ltd - Defibrillator/pacemaker) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/12/2021 |
| Responsible Entity |
|
| Reason/Issue |
It is possible when the device is placed on the patient during use (with the charge contacts in contact with the skin), or when the patient and the device are lying on wet ground and charging contacts come into contact with the ground, that a defibrillation shock cannot be delivered.
In these cases the device performs an internal safety discharge and shock delivery is cancelled. The device shows an electrode failure, although no such failure is present. The cause of the electrode fault message may be an impedance loop between the battery charge contacts of the defibrillator and the patient.
6 incidents have been identified since market launch in 2015. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
An exchange of the electronic defibrillation board will be carried out, as part of your next annual maintenance, from the beginning of the year 2022. Intermed Medical will contact you soon to plan this intervention, in the course of the year 2022. This new board eliminates the effects of the loop impedance described in 1. |
| Contact Information |
0499154957 - Intermed Medical Pty Ltd |