The Health Products Regulatory Authority (HPRA) has advised that a number of Defibtech Automated External Defibrillator (AED) pads supplied to 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, it added. 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.
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. 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. 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.
Products affected are:
DDP-100 Adult Defibrillation Pads: For use with AED Models: Lifeline and Lifeline Auto (DDU-1XX Series).
DDP-200P: Pediatric Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1XX Series).
DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, Lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series).
DDP–2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, Lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series).
Note: The affected AED Pads are for exclusive use with Defibtech AED models.
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. 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 are email: sales@oxygen-care.ie, phone: 01 276 9700.
