HeartSine Snags FDA Warning Letter

The FDA has told HeartSine Technologies that it is insufficiently addressing issues surrounding a Class I-level global recall of its Samaritan defibrillators.The FDA's Warning Letter to the company (based out of Newtown, PA and Belfast, Northern Ireland) is dated February 3, and comes about a year and a half after the late 2012 recall. The recall involves a possible battery defect that may cause the company's Samaritan 300 and Samaritan 300P Public Access Defibrillators (PADs) to turn on and off without warning, depleting the battery and potentially rendering the device useless when needed. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. It should be noted that these are not implanted devices; they are public-access defibrillators installed in places such as airports. They must be available on demand to save lives. Due to the defects, the defibrillator may not be able to deliver corrective therapy to a patient experiencing cardiac arrest.

In the latest Warning Letter, FDA makes reference to its inspection of the company's plant in Newtown, PA, during August 2013. It cites the firm for failing to make required Medical Device Reports (MDRs) within the allowed 30-day timeframe; for failure to adequately develop, maintain, and implement written MDR procedures; and for failure to keep adequate records tracking the serial number, owner, and location of each device.On the plus side, FDA told HeartSine that they had determined that the company's responses to a previous Warning Letter "appear sufficient to address the Quality System (QS) deficiencies identified," but reminded them that the procedures (and applicable federal regulations) had to be followed. FDA also acknowledged HeartSine's voluntary recall actions before FDA's official Class I recall action was initiated in September 2012. The agency said those voluntary measures would be evaluated on FDA's next visit.The defibrillators affected by the recall were manufactured and distributed between August 1, 2004 and January 31, 2011.