The Health Products Regulatory Authority has urged users of Defibtech defibrillator pads to immediately check their pads as they may have been labelled with incorrect expiry dates.
A number of defibrillator pads supplied to the Irish market have been labelled with incorrect expiry dates, the HPRA said.
It said that the issue specifically affects Defibtech Automated External Defibrillator (AED) pads which were affixed with unauthorised labels.
The labels, which were applied outside of Defibtech's control, provide an incorrect expiry date which could lead to the expired pads being used after their shelf life, the HPRA added.
The use of expired pads, it said, could potentially result in "a poor electrical connection and reduced energy delivered to a patient".
Defibtech currently has approximately 6,200 defibrillators on the Irish market. It is not known what proportion of this figure relates to the affected products.
It is estimated that there are over 10,000 defibrillators at locations across Ireland, with recent drives to encourage all sports grounds, schools and community facilities to have a defibrillator on site.
Defibtech has issued a Field Safety Notice which highlights how to identify the affected pads and outlines actions which need to be taken by customers to arrange an exchange of the pads.
The HPRA said it has contacted some potentially impacted organisations directly and has urged users to check their defibrillator pads.
It said in some cases the authorised label, which provides expiry date information, appears to have been removed and replaced with an unauthorised label.
We have become aware of a safety issue relating to Defibtech AED pads.
— HPRA (@TheHPRA) October 16, 2024
Unauthorised labels have been applied to some affected pads. This could lead to expired AED pads being used.
If you have been supplied with these pads, please take urgent action and read the manufacturer's… pic.twitter.com/wRTMAmP0i7
The HPRA said those with an affected product should urgently contact Oxygen Care, Defibtech's Irish market distributor, to arrange a return and exchange for a new Defibtech AED Pad.
The affected products are as follows:
- 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)
