A WARNING HAS been issued over unauthorised labels on some defibrillator pads which display an incorrect expiry date.
The Health Products Regulatory Authority (HPRA) today said that a number of Defibtech Automated External Defibrillator (AED) pads supplied to the Irish market have been affixed with unauthorised labels.
These unauthorised labels, which the HPRA said were applied outside of Defibtech’s control, provide an incorrect expiry date.
The HPRA warned that this could result in expired AED pads being used after their shelf life.
This in turn could result in a poor electrical connection and reduced energy being delivered to a patient.
Defibtech has issued a Field Safety Notice (FSN) to customers highlighting the issue.
The FSN details how to identify an affected AED pad and outlines the actions required to arrange for the removal and exchange of an affected AED pad.
The HPRA has also directly contacted a number of organisations that could be impacted and is urging users to immediately check their AED pads.
The HPRA is the regulatory authority for medical devices in Ireland, and Defibtech is working with it to further investigate the matter and its impact on customers, as well as to assess the total number of pads affected.
It’s understood that the authorised labels on a number of AED electrode pads were removed and an unauthorised label was then 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.
The affected AED Pads are for exclusive use with Defibtech AED models and include:
Defibtech and the HPRA are advising customers who have one of the Defibtech AED models listed and have purchased Defibtech AED pads to immediately inspect the product label.
Those with affected products should 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.
To embed this post, copy the code below on your site
have your say