Recalls

Public access defibrillator recalled due to power/battery defect

emergency defibrillator 1 Public access defibrillator recalled due to power/battery defectAnother public access cardiac defibrillator model is being recalled by the manufacturer due to a defect that could delay or prevent treatment to a patient during a cardiac event. The recall comes six months after the Food and Drug Administration (FDA) proposed more oversight for makers of emergency external defibrillators due to dozens of recalls of the devices and about 45,000 reports of device failures in the past seven years.

Automated external defibrillators (AEDs) are life-saving devices that send a jolt of electric current to the heart of individuals who are unconscious and suffering from cardiac arrest. The jolt is given in order to restore a normal heart rhythm. In conjunction with early bystander cardiopulmonary resuscitation (CPR), rapid defibrillation can contribute to the survival of adult victims of sudden cardiac arrest.

At a professional conference in 1994, a consensus was reached on providing more general public access to defibrillators. As a result, AEDs were placed at public gathering areas across the country including amusement parks, grocery stores and other venues.

However, the good intentions of the devices have fallen short due to malfunctions that have interrupted or delayed defibrillator treatment or caused unintended shocks to patients. This led the FDA to meet with manufacturers of defibrillator devices to determine the best way to test the devices to reduce the number of malfunction reports.

Unfortunately, the reports continue to come in. This week, HeartSine Technologies issued a recall of the Samaritan 300/300P Public Access Defibrillator (PAD) due to power and battery issues that cause the device to shut off. This can render the device unable to deliver therapy during a cardiac event, which can result in death or other serious injury.

The affected devices include the following serial numbers: 0400000501 to 0700032917; 08A00035000 to 10A00070753; and 10C00200000 to 10C00210106. The affected devices were manufactured from August 2004 to December 2010 and have a warranted life of seven years. The recalled defibrillators were distributed worldwide.

Customers with affected devices should contact the company for a free upgrade kit.

Source: FDA