Device Dossier
Physiologic-monitoring defibrillation system
Device Dossier for Physiologic-monitoring defibrillation system (Physiologic-monitoring defibrillation system, Class IIb, sponsor Device Technologies).…
- GMDN category: Physiologic-monitoring defibrillation system
- Sponsor: Device Technologies
Intended purpose
A device that incorporates a noninvasive temporary pacemaker or that can be retrofitted with an optional pacing attachment. This device applies an electric shock to establish more normal rhythms in hearts experiencing ventricular fibrillation, displays the electrocardiogram (ECG), and is capable of applying electrical impulses that stimulate the entire heart simultaneously to resuscitate the patient, correct arrhythmias, or temporarily pace. An ECG monitor included with the unit displays the ECG, allowing verification of arrhythmia and treatment effectiveness.