Adverse Events

Information about adverse events found in published literature related to the Vocera Communications EMDAN product.

Introduction

This section of the Directions For Use (DFU) is intended to provide information about any adverse events found in published literature.

Adverse Events

Numerous adverse events are reported in the FDA MAUDE database for secondary alarm notification systems. In the majority of these adverse events, the outcome was patient death. The following sample reports are representative of adverse events occurring with secondary alarm notification systems:

Users should be sure to be familiar with Vocera Communications Engage Medical Device Alarm Notification directions for use and to review the section on Safety Warnings.