The U.S. Food and Drug Administration (FDA) recently mandated that HeartSine Technologies recall its Samaritan 300/300P public access defibrillators manufactured from August 2004 to December 2010 because of their battery defects.
The devices have been linked with 5 deaths. The defibrillators were found to randomly turn off and on, depleting the device’s battery life. Similarly, some defibrillators were found to shut themselves off after misreading temporary changes in battery voltage. The FDA found that the defect was so serious that a Class I recall was necessary.
Public access defibrillators (“PADs”) are used to treat the victims of cardiac arrest before the patient can be brought to a hospital. Studies have shown that the availability of PADs can greatly increase the survival rate of heart attack victims. One study in the New England Journal of Medicine found a survival rate of almost 23% where the heart attack victim was met with volunteer responders equipped with PADs, but the survival rate dropped below 14% when the responders were only trained in CPR.