HeartSine Technologies, the maker of Samaritan public access defibrillators, is voluntarily recalling its 300/300P devices because of a potential drain on batteries that could affect delivery of therapy in people experiencing sudden cardiac arrest.
The affected devices may intermittently turn off and on, depleting battery power. The company also announced that devices with early versions of software used to manage the battery may misinterpret voltage drops as a sign of a low battery and shut down the device. Both circumstances may prevent the device from delivering therapy.
The affected public access defibrillators were manufactured between August 2004 and December 2010 and have serial numbers of 0400000501 to 0700032917, 08A00035000 to 10A00070753 and 1C00200000 to 10C00210106. The company reported that it will send customers a new reserve PAD-PAK and hang tag with instructions as well as a software upgrade.
Customers are encouraged to arrange receipt of the free upgrade kit immediately. Physicians and patients can report adverse events and side effects related to affected devices to the FDA.