Heartsine Technologies, a medical device manufacturer based in the United Kingdom, received Class I recall status from the United States Food and Drug Administration for its Samaritan defibrillators. According to a warning issued by the FDA, the defibrillators may have a battery defect that could lead to serious injury or death.
According to the FDA report, Samaritan 300 and Samaritan 300P defibrillators may turn on and off without warning. Since these public access defibrillators must be available on-demand to save lives, this issue can impact patient safety and wellbeing. In some cases, the defibrillator may not be able to deliver corrective therapy to a patient experiencing cardiac arrest.
Heartsine Samaritan defibrillators affected by the Class I FDA recall were distributed and manufactured between August 1st, 2004 and January 31st, 2011.
As of now, there have been no deaths conclusively linked with the battery issues in Heartsine Samaritan defibrillators. However, there have been five deaths reported to the FDA that may be linked with the use of the defibrillator system. Since patients requiring the use of a defibrillator are often in cardiac arrest, death from a failed defibrillation is not uncommon.