HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The ...



HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable external defibrillator, offering two modes of operation for defibrillation: manual mode and semi-automatic mode (AED). In manual mode, the HeartStart MRx is a full featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS). Manual operation allows users to select energy levels for external and internal defibrillation. Users may also perform synchronized cardioversion. Non-invasive external pacing is a device option. In AED mode, the HeartStart MRx allows the provider who is trained in Basic Life Support (BLS) to provide defibrillation therapy. The device analyzes a patient s rhythm and advises the user to deliver a shock. Voice prompts guide the user through the defibrillation process by providing instructions and patient information. The voice prompts are reinforced by messages that appear on the display. In both modes of operation, the HeartStart MRx utilizes impedance compensating biphasic truncated exponential therapy waveform. The HeartStart MRx can also be used for ECG monitoring of a patient using 3, 5 or 12 lead cables.
Components:
Recall Date:    Jul 16, 2019
Mfg:
Philips North America, LLC
Mfg Country:
United States
Recall ID:    83576
Product ID:    175784
Enforcement Date:    Sep 18, 2019
Last Published:    Sep 6, 2019

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Emert Number:    Z-2488-2019
Emert Status:    Announced