Initiated September 13, 2012, the Class I Recall involves the HeartSine Samaritan 300/300P public access defibrillator (PAD), manufactured and distributed from August 1, 2004 to January 31, 2011.
Intended for use on patients experiencing sudden cardiac arrest, HeartSine Technologies Ltd, Belfast, Northern Ireland (distributed by HeartSine Technologies, Newtown, Pa), recalled the defibrillators because certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.
No deaths or injuries have been reported to date associated with the on/off issue. To date, HeartSine has received five reports of death for which the company has not been able to rule out the possibility that the events may have been related to the battery management software issue.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
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