[Posted 09/17/2013]

AUDIENCE: Consumer, Emergency Medicine

ISSUE: Certain Samaritan 300/300P PAD devices manufactured before December 2010 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 and subsequently turn the device off. In certain instances, 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 inclusive are affected by one or both of these issues:

• 0400000501 to 0700032917
• 08A00035000 to 10A00070753
• 10C00200000 to 10C00210106

BACKGROUND: The potentially affected Samaritan 300/300P PADs were manufactured from August 2004 to December 2010 and have a warranted life of 7 years. Potentially affected devices were distributed globally.

RECOMMENDATION: If you have a device that is affected by this issue and you HAVE NOT contacted the company to receive a free upgrade kit, please do so immediately.

Because a device experiencing the on/off issue will function appropriately if it has an adequate power source, HeartSine is sending affected customers a new PAD-PAK to be held in reserve and an accompanying hang tag with instructions for when and how to insert the reserve PAD-PAK so that the customer always has the ability to deliver therapy in a rescue attempt. In addition, HeartSine is providing a software upgrade (with a CD, data cable and associated User Manual) to bring all users up to a more recent version of the software that the company's data shows is no longer susceptible to the secondary issue. See the firm Press Release for additional instructions.

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

[09/13/2013 - Press Release - HeartSine Technologies, Ltd]  

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