U.K. medical device maker HeartSine Technologies launched a global correction of its Samaritan 300/300P public access defibrillators over concerns that the devices fail to provide life-saving shock therapy due to a pair of battery defects.
The devices have been loosely linked with 5 deaths that the company has not yet definitively deemed either related or unrelated to the battery issues, HeartSine reported.
Some lots of the Samaritan devices were found to intermittently turn off and on, depleting the device’s battery life, and certain devices with older battery management software inappropriately shut themselves off after misinterpreting temporary drops in battery voltage, according to a company statement.
HeartSine said certain Samaritan 300/300P PAD devices manufactured from August 2004 to December 2010, which carry a warranty of 7 years,are affected by the correction. Affected lots include those with the following serial numbers:
- 0400000501 to 0700032917
- 08A00035000 to 10A00070753
- 10C00200000 to 10C00210106
HeartSine plans to send customers a new PAD-PAK with instructions for when and how to insert the reserve PAD-PAK so that users can delivery therapy in rescue attempts. The company is also providing a software upgrade for devices running older battery management software.
