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Medtronic AEDs in UK device alert:

This article was originally published in Clinica

Executive Summary

Problems with the energy discharge levels of some models of Medtronic's Lifepak 12 automatic external defibrillator have led the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to post a device alert. The problem affects Adaptiv biphasic (and not monophasic) devices that have undergone software reinstallation or upgrade. This may have resulted in inadvertently resetting the device's output level to a default setting of 125 joules, instead of between 200 and 360 joules. Under the lower setting, which is below the Resuscitation Council UK guidelines, there is a greater risk of unsuccessful defibrillation. The National Defibrillator Programme, which is about to complete the installation of 3,000 AEDs in public places, no longer uses Medtronic's defibrillators, opting instead for Cardiac Science's Powerheart G3 AED (see this issue, p X).

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