| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00581-1 |
| Product Name/Description |
DEFIGUARD Touch 7
Devices: All
ARTG 107242
(Intermed Medical Pty Ltd - Defibrillator/pacemaker) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
Failure in the defibrillation shock delivery control circuit of the DEFIGARD Touch-7 has led to shocks not being delivered when the device is used. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
· It is recommended to keep the devices in service in view of the benefit-risk ratio for the patient.
· The proper working of shock delivery can be verified by delivering shocks into a defibrillation simulator (deliver 3 consecutive shocks at the energy configured by default).
· If the device were to cancel a shock for no apparent reason, follow the resuscitation protocol supported by the voice prompts and have the device inspected by your maintenance department.
· A new software version is being developed that will correct the fault. SOFT10B16 Following that software release a potential fault in the shock delivery circuit will be detected by all the periodic self-tests and reported by an alarm.
· You will receive information from InterMed as soon as the software becomes available. The software is scheduled for release in July 2024. Once available update your device with the new software, using the procedure described in paragraph 10.3 in the Instructions for Use. |
| Contact Information |
1300 123 633 - Intermed Medical |