| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00177-1 |
| Product Name/Description |
Powerheart G3 Defibrillation Electrodes (used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E Automatic External Defibrillator (AEDs))
Part Number: 9131-001
Lot Number: 141125-02
ARTG Numbers: 98893, 113431 and 101284 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
Cardiac Science has determined Powerheart G3 defibrillation electrodes from Lot No. 141125-02 may exhibit higher than expected electrical impedance over time. If electrode impedance becomes too high, the Powerheart G3 Automatic External Defibrillator (AED) will fail the electrode self-test performed by the AED and it will not be Rescue Ready. Specifically, if the AED fails the electrode self-test, the STATUS INDICATOR on the AED will be RED and the AED will beep. This is standard behaviour when the impedance limit is exceeded. The AED will not be ready for use in a rescue in this state.
The reported issue may result in failure to deliver shock therapy when needed and in the worst case could result in serious adverse health consequences, including injury or death. Cardiac Science is not aware of any instances in which Lot No. 141125-02 electrodes failed to work at the time of therapy. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to identify the affected units and replace the electrodes with the replacement electrodes provided by the sponsor as per the instructions in the customer letter.
This action has been closed out on 29/10/2018 |
| Contact Information |
03 9429 2666 - Cardiac Science Technical Support |