HPRA warns of unauthorised labelling on some defibrillator pads in Longford 

The Health Products Regulatory Authority (HPRA) is advising that a number of Defibtech Automated External Defibrillator (AED) pads supplied to Longford and the wider the Irish market have been affixed with unauthorised labels.

The unauthorised labels, which were applied outside of Defibtech’s control, provide an incorrect expiry date.

This could lead to expired AED pads being used after their shelf life which, in turn, could potentially result in a poor electrical connection and reduced energy delivered to a patient.

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Defibtech has issued a Field Safety Notice (FSN) to highlight this issue.

The FSN details how to identify an affected AED pad and outlines the actions to be taken by the customer / user to arrange for the removal and exchange of an affected AED pad.

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The HPRA has also contacted a number of potentially impacted organisations directly to further raise awareness of the issue and is urging users to immediately check their AED pads. 

Defibtech is working with the HPRA, the regulatory authority for medical devices in Ireland, to further investigate this matter and its impact on affected customers, as well as to assess the total number of pads affected.

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Information available to-date suggests that on a selected number of AED electrode pads the authorised label, which provides information on the expiry date, appears to have been removed and an unauthorised label applied outside of Defibtech’s control. This could potentially lead to an expired AED Pad appearing as though it is within the acceptable use range.

Defibtech and the HPRA are advising that customers who have one of the Defibtech AED (models listed above) and have purchased Defibtech AED pads to immediately inspect the product label as per Defibtech’s guidance in its FSN.

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Those with affected product should urgently contact Oxygen Care, Defibtech’s new Irish market distributor, to arrange a return and exchange for an authorised labelled Defibtech AED Pad free of charge.

Oxygen Care contact details:

• Email: sales@oxygen-care.ie
• Phone: 01 276 9700
• Address: 2 Holfeld Business Park, Kilmacanogue. Co. Wicklow. Eircode: A98 NP27

Affected customers can obtain further information or support from Defibtech at +1 (203) 453-4507 or techsupport@defibtech.com