HeartSine Samaritan 300/300P PADs, Off/On issue, battery management software issue.
Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted.
HeartSine Announcement
Posted 10/27/2012 FDA Link
