IMB Advises on Automated External Defibrillators
26 November 2004
The Irish Medicines Board (IMB) stated that healthcare professionals throughout the country have been advised of the recall of Automated External Defibrillators (AEDs) manufactured by Access CardioSystems Inc., which are used for cardiac conditions. The IMB as the regulatory authority for medical devices in Ireland has been closely monitoring this product recall and issued a safety notice in mid November giving details of the affected AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator devices. It informed healthcare professionals that the devices with the appropriate serial numbers should be immediately removed from use. The IMB have communicated with healthboards, hospitals, General Medical Practitioners (GP) and Dental Professional Bodies to date.
The IMB is continuing to act as a resource to healthcare professionals on this issue. A safety notice with further information was published on the 15th November and is available on www.imb.ie. The safety notice lists those distributors that have supplied these products to the Irish market. The IMB have been in close communication with the distributors who have confirmed that they have been liaising directly with their customer base. The IMB is confident that the issue has been communicated to customers who purchased these devices through the official distribution network.
The two potential issues involving specified serial numbers of AED''s are: the possible failure of the shock delivery circuit and the potential of the AED to turn on unexpectedly. The IMB states that these automated external defibrillators (AED''s) may be in use in hospitals, GP practices, and dental practices or in some public areas. All relevant devices with appropriate serial numbers should be immediately removed from use. All other AED''s manufactured by Access CardioSystems Inc not specified in the scope of the recall should be replaced as soon as possible.
The serial numbers of the devices recalled by the manufacturer, Access CardioSystems Inc, are:
The IMB has also informed healthcare professionals that disposable parts used with all Access CardioSystems AEDs (including those not affected by the recall) will no longer be available from manufacturer. Access CardioSystems has ceased trading and has discontinued manufacturing and marketing all models of AEDs.
- AccessAED PAD (model numbers 9100-0010-0 and 9100-0015-0)
- AccessAED (model numbers 9100-0100-0, 9100-0100-1, 9100-0150-0, and 100-0150-1)
- AccessALS (model numbers 9100-0100-2 and 9100-0150-2)
The IMB is available to healthcare professionals to provide further advice on this matter through its Medical Devices Department. A detailed safety notice is also available on www.imb.ie.
Siobhan Molloy / Gillian Martin,
Weber Shandwick FCC
Tel: (01) 676 01 68 Or (086) 817 50 66/ (087) 6686619