Medi-Trace Combination Defibrillation & ECG Electrode for Hewlett Packard Defibrillators

• 2 recalls, same reason

  • Terminated Z-0047-2015 FDA Class I ·initiated 18 Sep 2014
  • Terminated Z-0046-2015 FDA Class I ·initiated 18 Sep 2014

  Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

510(k) Number

K955882 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What clinical scenarios is this electrode designed to support during cardiac emergencies?

  The Medi-Trace Combination Defibrillation & ECG Electrode is specifically designed for simultaneous electrocardiogram (ECG) monitoring and defibrillation during cardiac emergencies, such as ventricular fibrillation or pulseless ventricular tachycardia. Its dual-function capability allows clinicians to assess heart rhythms and deliver shocks in real-time, which is critical for rapid intervention in settings like emergency rooms, pre-hospital environments, or cardiac care units.

• Is this electrode reusable, or is it intended for single-use only?

  This electrode is explicitly supplied as a single-use device. It adheres to standard single-use medical device protocols to maintain sterility and functionality, ensuring each unit is intended for one-time clinical use only.

• What defibrillator models is this electrode compatible with, and are there any age restrictions?

  The Medi-Trace Combination Defibrillation & ECG Electrode is designed exclusively for use with Hewlett Packard defibrillators. It is not approved for use on children or infants, and its intended use is limited to adult patients in clinical settings.

• How should this electrode be stored to ensure proper functionality and sterility?

  Since this is a single-use device, storage must follow standard protocols for single-use medical devices to preserve sterility and functionality. The manufacturer recommends adhering to general guidelines for sterile medical electrodes, including protection from contamination, moisture, and extreme temperatures.

• What regulatory pathway was followed for FDA clearance, and what classification does it fall under?

  The Medi-Trace Combination Defibrillation & ECG Electrode received FDA clearance through a 510(k) premarket notification (K955882) under the classification of Automated External Defibrillators (Non-Wearable). It was determined to be substantially equivalent to a predicate device and falls under regulation number 870.5310, with review by the Cardiovascular (CV) Advisory Committee.