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.
The manufacturer, HeartSine Technologies, Limited, of Northern Ireland says it hasn’t received any reports of deaths tied directly to the on/off malfunction, but it is investigating 5 fatalities that may have been caused by problems with the battery power management. The FDA is asking patients and physicians to report adverse events through its online MedWatch system.
HeartSine 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 devices were manufactured between August 2004 and January 2011, and have a warranted life of 7 years.
HeartSine’s letter to customers included instructions on ensuring the affected PADs would be functional when needed.
Because a device experiencing the on/off issue will function appropriately if it has an adequate power source, HeartSine has sent 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.
Consumers with questions can contact HeartSine by calling (877) 877-0147 or by email at firstname.lastname@example.org.