HeartSine has been warned by the U.S. Food and Drug Administration (FDA) over its medical device reporting and tracking violations, Mass Device reports. The company was issued a warning letter for failing to properly report medical devices and have tracking violations at a Pennsylvania.
HeartSine was warned over its “failure to adequately develop, maintain and implement written [medical device reporting] procedures”. Additionally, the FDA said, the company misbranded its automated external defibrillators. The agency pointed out another citation over late adverse event reporting, which had been addressed already. The FDA’s adverse event reporting system is used to track any side effects, complications or injury related to a drug or medical device.
The FDA noted a number of things lacking in HeartSine’s reporting system, including lack of sufficient documentation, missing some key definitions and recording-keeping and protocols for follow-up with the agency. The agency also said that the company “failed or refused” to submit required device documents, including contact information and device tracking system audits. Furthermore, HeartSine also failed to conduct regular tracking system audits.
The warning is only making things worse for HeartSine, whose Samaritan defibrillators were issued a Class I recall, the agency’s most serious recall status, late last year. When a device is issued a Class I recall, it means that it can cause serious injury or death.
