A warning has been issued in relation to unauthorised labels on some defibrillator pads supplied to the Irish market which display an incorrect expiry date.
The Health Products Regulatory Authority (HPRA) is today advising that a number of Defibtech automated external defibrillator (AED) pads have been fixed 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.
"Defibtech has issued a field safety notice to highlight this issue. This details how to identify an affected AED pad and outlines the actions requires to arrange for its removal and exchange.
"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 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.
Customers who purchased one of the Defibtech AED models listed below with Defibtech AED pads have been asked to inspect the product label.
Those with affected products are asked to contact Oxygen Care, Defibtech’s new Irish market distributors, to arrange a free return and exchange for an authorised labelled Defibtech pad.
