The pads have been affixed with unauthorised labels that provide an incorrect expiry date.
The Health Products Regulatory Authority (HPRA) is issuing a warning regarding a number of Defibtech Automated External Defibrillator (AED) pads distributed in Kildare and across Ireland.
The pads have been affixed with unauthorised labels that provide an incorrect expiry date.
The HPRA advises that the unauthorised labels were applied outside of Defibtech's control and could lead to expired AED pads being used beyond their shelf life.
This could potentially result in a poor electrical connection and reduced energy delivered to a patient during an emergency.
Defibtech has issued a Field Safety Notice (FSN) to address the issue, detailing how to identify affected AED pads and outlining the necessary steps for customers and users to take.
The HPRA has also contacted impacted organisations to raise awareness and is urging all users to immediately check their AED pads.
Defibtech is collaborating with the HPRA, the regulatory authority for medical devices in Ireland, to investigate the matter further and assess the total number of affected pads.
Preliminary information suggests that unauthorised labels have been applied to a select number of AED electrode pads, potentially obscuring the correct expiry date.
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