HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall - Device May Intermittently Turn On and Off

[Posted 11/19/2012]

AUDIENCE: Risk Manager, Health Professional

ISSUE: HeartSine notified customers that 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.

Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall:

• 0400000501 to 0700032917
• 08A00035000 to 10A0070753
• 10C00200000 to 10C00210106

Affected devices were manufactured and distributed from 08/01/2004 to 01/31/2011.

BACKGROUND: Samaritan 300/300P PAD devices are intended for use on patients experiencing sudden cardiac arrest.

RECOMMENDATION: The firm issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/19/2012 - Recall Notice - FDA]