The US Food & Drug Administration (FDA) has warned users that as many as 280,000 external defibrillators may malfunction during attempts to rescue people with sudden cardiac arrest.
Faulty components in 14 defibrillator models built by Cardiac Science Corporation of Bothell, Washington, USA, may cause the devices to fail while delivering a shock used to restore normal heart rhythm when sudden cardiac arrest occurs.
The affected models may also interrupt electrocardiography (ECG) analysis, fail to recognise electrode pads and interference or background noise that makes the device unable to accurately analyse heart rhythm.
The FDA suggests that hospitals, nursing homes and other high-risk settings use alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators and recommends to use the affected devices only when alternatives are not immediately available
Cardiac Science issued a software update for two of its Powerheart defibrillators, which were recalled in February 2010, and plans to issue similar software updates for other affected devices.
