BELFAST, United Kingdom--(BUSINESS WIRE)-- On September 13, 2012, HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan® 300/300P PAD public access defibrillators to address two separate issues that may affect the ability to deliver therapy to a patient in a sudden cardiac arrest (SCA) event, if needed. 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.
The potentially affected Samaritan 300/300P PADs were manufactured from August 2004 to December 2010 and have a warranted life of 7 years. Samaritan® 300/300P PAD devices with the following serial numbers inclusive are affected by one or both these issues:
- 0400000501 to 0700032917
- 08A00035000 to 10A00070753
- 10C00200000 to 10C00210106
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.
HeartSine has requested that customers take the following actions to ensure that they are able to provide therapy in the event that a sudden cardiac arrest event occurs:
The firm voluntarily issued a correction for this product after becoming aware of the above issue. FDA is aware of the action and the steps the company is taking. 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.
Consumers with questions may contact the company at 1-877-877-0147 between the hours of 8:00 am and 5:00 pm ET and email at firstname.lastname@example.org.
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or
- Call FDA 1-800-FDA-1088
Source: HeartSine Technologies, Ltd.