HeartSine hit with Class I over defibrillator recall
|HeartSine is warning of a potentially fatal glitch in its Samaritan defibrillator--courtesy of HeartSine|
HeartSine launched a global recall of its Samaritan defibrillators after 5 deaths possibly related to a malfunction in the devices, and the FDA has slapped the affair with its most serious label, warning of serious injury or fatality.
In September, the Irish devicemaker launched a worldwide correction, warning customers that some Samaritan 300/300P models had been found to intermittently switch on and off, depleting the battery and possibly rendering them inoperable during a cardiac event. Furthermore, some devices have a software glitch that can misinterpret battery life and shut the unit off unnecessarily.
HeartSine says it hasn't received any reports of deaths tied directly to the malfunction, but it is investigating 5 fatalities that might be related. The FDA is asking patients and physicians to report adverse events through its online MedWatch system.
The company said it has sent backup power sources to affected customers, warning them to keep the reserves on hand should the device fail during a cardiac event.
The affected devices were manufactured between August 2004 and January 2011.
- read the FDA notice