Device Category Dossier

Non-rechargeable public automated external defibrillator

Device Category Dossier for Non-rechargeable public automated external defibrillator. Australian ARTG records, sponsors, device class — compiled by…

External defibrillators analyse the heart rhythm after pads are applied and deliver therapy in semi-automatic or fully automatic modes, with semi-automatic units requiring operator activation of shock delivery whilst fully automatic units deliver it automatically, and entering cardiopulmonary resuscitation mode with audio and visual guidance if the rhythm is non-shockable. These devices treat adults and paediatric patients experiencing sudden cardiac arrest with ventricular fibrillation, pulseless ventricular tachycardia, or ventricular flutter, and are suitable for use in public places, healthcare facilities, and emergency response environments by trained laypersons or healthcare professionals.