Automated External Defibrillators

An automated external defibrillator (AED) is a medical device that analyses a person’s heart rhythm and, when needed, delivers a shock to sudden cardiac arrest (SCA) victims who are in a shockable heart rhythm.

A defibrillator can play a potentially lifesaving role. Used correctly, it can improve a person’s survival chances following SCA. Therefore, defibrillators need to be easy to access and in good working order at all times in the event that they are needed for an emergency. Failure to maintain defibrillators in accordance with manufacturer’s recommendations may result in the devices not working as intended in an emergency.

Regular servicing and maintenance 

Regular servicing and maintenance are crucial to ensure that an AED remains in good working order. Our AED information leaflet contains recommendations for storing and maintaining the device correctly. This leaflet also provides advice on selecting and purchasing an AED for use in a community setting.  

Urgent corrective actions

When urgent corrective actions are required to prevent or reduce the risk of an AED failing to perform correctly, the AED manufacturer or their representative communicates this information in a document called a field safety notice. If a field safety notice is available for your device, it is very important to complete the required actions immediately. Otherwise, the AED may not work properly when it is needed. 

All outstanding field safety notices for defibrillators on the Irish market are listed and linked below. Please check if there is a field safety notice below for your AED and if the necessary actions have been completed. If you need further information in relation to a specific action, please contact the device manufacturer.

Please note that some of these actions commenced a number of years ago. Despite efforts by the manufacturer to complete the action, they have not been able to make contact with the AED owner in all cases.

In addition to field safety notices, HPRA Safety Notices are listed below for some AED models. HPRA Safety Notices communicate issues identified through safety monitoring and/or market surveillance activities. They highlight additional details that are relevant to the Irish market or remind Irish customers to complete the corrective action previously identified by the manufacturer in a field safety notice.

Field Safety Notices and HPRA Safety Notices

Corrective actions are required for the AED models listed below. Please download the notices below for more information. 

FRED Easy, FRED Easy Skity (Schiller Medical)

Field Safety Notice

HeartStart FRx, HeartStart Home and HeartStart OnSite (Philips)

Field Safety Notice

HPRA Safety Notice

Infant Child Reduced Energy Electrodes for Physio-Control LIFEPAK defibrillators (Stryker)

Field Safety Notice

LIFEPAK 500 AED (Stryker)

Field Safety Notice

HPRA Safety Notice

LIFEPAK CR2 Defibrillator (Stryker)

Field Safety Notice

Life-Point (Metsis Medikal Teknik Sistemler Elektronik Otomoti)

Field Safety Notice

HPRA Safety Notice

 

Powerheart G3 Elite AED (Cardiac Science Corporation)

Field Safety Notice

 

Samaritan PAD, 300, 300P (Physio Control formerly HeartSine)

Field Safety Notice

HPRA Safety Notice

 

Telefunken AED Model HR1 & FA1 (Defiteq International B.V.)

HPRA Safety Notice (4 April 2019)

HPRA Safety Notice (15 June 2016)