Global Key SolutionsGKS
  1. Home
  2. /
  3. Records
  4. /
  5. Warning Letter
  6. /
  7. Heartsine Technologies Inc
WARNING LETTER
•Heartsine Technologies Inc•August 22, 2013

FDA WARNING_LETTER - Heartsine Technologies Inc - August 22, 2013

View on Dashboard

Your cart

Your cart is empty.

Browse public document pages and click Buy this document. We'll ask for your email at checkout, no account needed up front.

Browse documents
Record Details

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

Company
Heartsine Technologies Inc
Inspection Date
August 22, 2013
Product Type
Devices
Office
Philadelphia District Office
Person
  • Anne E. Johnson (Senior Science Advisor)
Open in Dashboard

ID · afedbfdd-5c86-4131-a630-bdf81a2911be

Violation Codes10
21 U.S.C. 321(h)21 U.S.C. 352(t)(2)21 U.S.C. 360i21 CFR 80321 CFR 803.50(a)(2)21 CFR 803.1721 CFR 803.50(b)21 CFR 803.20(c)(1)21 U.S.C. 360e21 CFR 821.25(b)

Full citation text and observation details available on the Dashboard.

footer
Global Key Solutions
Regulatory Data Transformed
Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
[email protected]
Quick Links
KeyPedia™ Lite
Legal & Ethics
©2026, Global Key Solutions All rights reserved.