inforMED
MKJClass III

Automated External Defibrillators (non-wearable)

Cardiovascular · 21 CFR 870.5310

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

MDR events268,697All time
Recalls334All time
Registered firms204Currently listed
510(k) clearances228All time

Recent MDR events

268,697 adverse event reports on file

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Event type breakdown

Malfunction260,163
Death4,510
Injury1,937
Unspecified1,519
Other568

Most-reported manufacturers

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Philips Medical Systems88,431Zoll Medical Corporation74,850Physio-control, Inc. - 301587621,788Philips North America Llc17,342Heartsine Technologies Ltd8,270Physio-control, Inc8,046Cardiac Science Corporation7,492Defibtech, L.l.c.5,067

Recalls

334 recall events for this product code

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Registered firms

204 firms currently registered for this product code

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510(k) clearances

228 clearances for this product code

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PMA approvals

17 premarket approvals for this product code

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