HeartSine Technologies is in more hot water with the FDA this month after receiving an agency warning letter citing medical device reporting and tracking violations at a Pennsylvania facility.
The FDA dinged HeartSine for "failure to adequately develop, maintain and implement written [medical device reporting] procedures" and misbranding of the company’s automated external defibrillators. Another citation over late adverse event reporting had been addressed already, the FDA noted.
The agency warned that HeartSine’s reporting system lacked sufficient documentation, missing some key definitions, record-keeping and protocols for follow-up with the FDA. The letter further claimed that HeartSine "failed or refused" to provide required device documentation such as contact information and device tracking data and that the company failed to conduct regular tracking system audits.
The letter is more bad news for HeartSine, which late last year received the FDA’s highest-risk Class I label for a recall of the company’s Samaritan defibrillators. The FDA said that battery concerns could lead to patient injury or death.
HeartSine had also issued a global recall for the Samaritan devices in October 2012 following reports of 5 deaths that may have been related to failures in Samaritan 300/300P public access defibrillators.