Samaritan Defibrillators Require Corrective Action by HeartSine

Posted on October 25, 2012

A medical device company is making it known that one of their products needs to be corrected in order to be able to ensure that the item works properly.

The item requiring the correction is the Samaritan 300/300P PAD public access defibrillator, and the announcement was made by HeartSine Technologies.  Affected units were produced between August 2004 and December 2010.  Each one has a warranty of seven years.

There are two potential issues that could hinder the proper usage of these defibrillators in the event that somebody suffers some type of cardiac event and needs immediate assistance.  First, there exists a software issue plaguing early models of the items wherein the system inaccurately detects a temporary battery voltage drop as a low battery situation.  As a result, the machine might get turned off.  The other issue stems from the possibility that the defibrillator could potentially turn off and on without prompting.  This could lead the batter to lose power over time.

The danger from the latter issue is reportedly mitigated if the owner has an appropriate power source that offsets the depleted battery.  However, the company will still be giving out PAD-PAKs to affected customers along with instructions detailing how to use the pak during a rescue.  That way, assistance will always be possible.

A software upgrade should be able to take care of the other issue.  The on/off risk has not led to any reported injuries or fatalities, but five fatality reports have been received by HeartSine in which the company has yet to rule out the software error as being related to the incident.

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