Class I Recall Issued For Samaritan Defibrillators
The U.S. Food and Drug Administration (FDA) issued a Class I recall of some Samaritan defibrillators made by HeartSine due to battery problems that could lead devices to switch on and off during a cardiac event and lead to the injury or death of a patient.
A Class I recall is the most serious safety warning issued by the agency.
The FDA said that the U.K. manufacturer notified customers that certain Samaritan 300/300P public access defibrillators (PADs) may intermittently turn on and off, which may deplete the battery the over time. Separately, some of the 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.
Either of these conditions could cause the device to fail to deliver life-saving shock therapy during a serious cardiac event.
The lots of the device that were affected by the recall are the ones manufactured between August 2004 and December 2010 and carried a seven-year warranty. They are:
• 0400000501 to 0700032917
• 08A00035000 to 10A0070753
• 10C00200000 to 10C00210106
No deaths or injuries associated with the on/off issue have been reported. 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.
In October, HeartSine launched a global correction for potential battery issues in its Samaritan 300/300P PADs.