FDA Class I Recall For HeartSine Samaritan Public Access Defibrillator 300/300P

In short

The FDA has issued a Class I recall, it’s highest category, for the HeartSine Samaritan 300/300P Public Access Defibrillator (PAD) which seems to be suffering battery depletion and software issues which may prevent it being able to dispense its therapeutic dose.

Background

HeartSine Technologies Ltd is based in Belfast Northern Ireland and has enjoyed considerable success with its so-called public access defibrillators. In September it announced by letter that its Samaritan 300/300P PAD devices were suffering from certain problems that may affect their function. The devices implicated in what has now become an FDA Class I recall were manufactured and distributed between August 2004 and January 2011 have the following serial numbers:

0400000501 to 0700032917

08A00035000 to 10A0070753

10C00200000 to 10C00210106

It seems 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.

HeartSine has requested that customers follow the instructions detailed in their letter dated Sept. 11, 2012 to ensure that affected devices are able to provide therapy if a sudden cardiac arrest event occurs.

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.

Source: FDA, HeartSine Technologies Ltd