NSAClass IIILife-sustaining

Over-the-counter Automated External Defibrillator

Cardiovascular · 21 CFR 870.5310

Automated external defibrillators are devices that 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 over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.

MDR events1,803All time

Recalls2All time

Registered firms9Currently listed

510(k) clearances1All time

Recent MDR events

1,803 adverse event reports on file

Event type breakdown

Malfunction1,756

Death31

Injury15

Unspecified1

Most-reported manufacturers

Philips North America Llc832 Philips Medical Systems656 Heartsine Technologies Ltd263 Philips North America Llc20 Philips Medical Systems (htst)12 Physio-control, Inc. - 301587610 Philips Medical Systems (htst Returns)4 Heartsine Technologies Ltd2

Recalls

2 recall events for this product code

Registered firms

9 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Philips Medical SystemsSep 16, 2004
K040904 · PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A