Power Problems Lead to Heartsine Defibrillator Recall

Federal health regulators are warning about problems with HeartSine Samaritan Public Access Defibrillators (PAD), which may cause them to turn on and off at random, potentially draining the batteries. 

The FDA announced a Samaritan PAD 300/300P recall on November 19, giving it a class 1 designation; the most serious recall classification. This suggests that continued use of the device may pose a risk of serious injury or death.

The defibrillators are designed for emergency use in public areas, and problems with a lack of power from dead batteries may cause the devices to fail when they are needed.

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Although no injuries have been directly connected to the on/off issues, the manufacturer is continuing to investigate at least five deaths that may have been caused by problems with the battery power management.

The manufacturer, HeartSine Technologies, Limited, of Northern Ireland, sent out a letter to customers in September, warning that the defibrillators may intermittently turn on and off, eventually depleting the battery. They also have an unrelated software problem where a temporary drop in battery voltage causes the devices to turn off. Either problem could lead to the device not delivering a life-saving electrical shock when needed.

The recall affects Samaritan 300/300P Public Access Defibrillators with serial numbers ranging from 0400000501 to 0700032917, 08A00035000 to 10A0070753, and 10C00200000 to 10C00210106. The affected PADs were manufactured and distributed from 08/01/2004 to 01/31/2011.

HeartSine’s letter to customers included instructions on ensuring the affected PADs would be functional when needed. Consumers with questions can contact HeartSine by calling (877) 877-0147 or by email at heartsine6265@stericycle.com.

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