The Medicines and Healthcare products Regulatory Agency (MHRA) has posted a field safety notice concerning G3 Elite AED, manufactured by Cardiac Science.

According to the MHRA, the manufacturer has recently received field reports of the affected devices where the Rescue Ready status indicator displays red and the Service LED is illuminated.

The manufacturer's investigation traced the problem to be a software anomaly associated with the Daylight Savings Time (DST). If the device is configured with the DST enabled, it will experience error code "0x99" after Daylight Savings. In this state, the device must be returned to the manufacturer to clear the error, but can be used clinically if an emergency arises.

The manufacturer is in the process of revising the software and will make the update available in order to prevent the anomaly from occurring. The manufacturer is asking owners to return the affected devices for update.

Owners are advised to do the following actions:

• Locate the affected devices.
• Alert all the affected users of this problem.
• AED that has failed its self-test should remove from service.
• Regardless of the self-test status, owners of the affected devices should contact the manufacturer's Technical Support Team or local representative to schedule an update.

According to the local supplier, the affected products have not been sold in Hong Kong.

For details, please refer to the following link:
https://mhra-gov.filecamp.com/s/CfQAgNVIiS7VaUKz/d

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 25 February 2020