FDA WARNING_LETTER - Heartsine Technologies Inc - August 22, 2013

This FDA Warning Letter, dated February 3, 2014, was issued to HeartSine Technologies, Ltd. following an inspection from August 13-22, 2013, at their Newtown, Pennsylvania facility. The firm manufactures Class III Automatic External Defibrillators (AED) devices, such as the PAD 300P.

The inspection revealed that HeartSine's AED devices are misbranded due to failures in Medical Device Reporting (MDR) and Medical Device Tracking requirements.

Key violations include: 1. **Failure to report MDRs within 30 calendar days:** The firm did not timely report information suggesting a device caused or contributed to death or serious injury, as required by 21 CFR 803.50(a)(2). An example cited was complaints related to a Samaritan 300P and Pad Pak malfunction linked to an open recall. The firm's response regarding this specific issue was deemed adequate, attributing the late reporting to (b)(4) and initiating corrective actions. 2. **Failure to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17):** * Procedure (b)(4) lacked internal systems for timely identification, communication, and evaluation of events, specifically omitting definitions for "caused or contributed," "serious injury," "reasonably known," and "reasonably suggests." * The