Adverse Event Report on Defibrillators

MRL, Inc. and FDA notified healthcare professionals of a voluntary worldwide Class I recall of 580 AED20 automatic external defibrillators because of an intermittent electrical connection that could result in failure, delay in analyzing the patient’s ECG or failure to deliver expected therapy and resuscitation of the patient. A Class 1 recall occurs when there is reasonable probability that use of or exposure to the product will result in serious adverse health consequences or even death.