Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack 1200MAH; BA

• • Terminated Z-2064-2011 FDA Unclassified (pre-2012) ·initiated 1 Apr 2011

  Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process

• • Terminated Z-0077-2011 FDA Unclassified (pre-2012) ·initiated 27 Aug 2010

  Data cards may include an incorrect format which may cause the AED to not function correctly.

• 2 recalls, same reason

  • Terminated Z-1781-2010 FDA Unclassified (pre-2012) ·initiated 21 May 2010
  • Terminated Z-1782-2010 FDA Unclassified (pre-2012) ·initiated 21 May 2010

  The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy

• • Terminated Z-0580-2007 FDA Unclassified (pre-2012) ·initiated 17 Feb 2007

  Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

510(k) Number

K013896 ↗

FDA Product Code

MKJ

Models / Variants

Sentry Semiautomatic External Defibrillator

External Defibrillation Pads (Electrodes) Ddp-100

Battery Pack 1200MAH

Ba

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

ST

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See all devices from Defibtech, LLC →

• What is the primary purpose of the Sentry Semiautomatic External Defibrillator and how does it guide users during resuscitation efforts?

  The Sentry Semiautomatic External Defibrillator is designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It provides voice prompts and shock advisories to guide trained responders—such as EMS personnel or healthcare professionals—through the resuscitation process, ensuring proper use in both prehospital and in-hospital settings.

• Are the external defibrillation pads (DDP-100) reusable, and if not, how long can they be stored before replacement is required?

  The DDP-100 external defibrillation pads are single-use only and must be replaced after each use. Additionally, they should be discarded if stored for more than two years, as per the manufacturer’s guidelines to ensure safety and effectiveness.

• What storage conditions are necessary to maintain the functionality and safety of the Sentry defibrillator and its battery pack?

  The Sentry defibrillator and its 1200mAh battery pack require storage in a dry, temperature-controlled environment. The device is not MRI-safe, so it should be kept away from magnetic fields. Proper storage conditions help preserve performance and longevity.

• How is the Sentry Semiautomatic External Defibrillator regulated in the United States, and what does its regulatory status imply for buyers?

  The Sentry defibrillator is authorized for use in the U.S. under FDA 510(k) clearance (K013896) and is classified as a Class III medical device. This means it has undergone rigorous review to demonstrate substantial equivalence to predicate devices, ensuring safety and effectiveness for automated external defibrillation in emergency cardiac situations.

• What components are included in the complete Sentry system kit, and how is the battery pack integrated into its operation?

  The Sentry system kit includes the defibrillator unit itself, the DDP-100 external defibrillation pads, and a 1200mAh rechargeable battery pack. The battery pack powers the device during resuscitation efforts, allowing for extended use in field or hospital settings where electrical outlets may not be readily available.