BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICS

    MDR report key: 2935391 · Received December 31, 2012

    Report

    Report Number
    2935391
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 17, 2012
    Report Date
    December 31, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CENTRAL MONITOR WHICH DISPLAYS PATIENT RHYTHMS AND VITAL SIGNS FROM BEDSIDE MONITORS SIMPLY STOPPED WORKING.======================MANUFACTURER RESPONSE FOR CENTRAL STATION MONITOR, ICS (PER SITE REPORTER).======================DRAEGER IS GOING TO EVALUATE THE FAILURE AND SEND REPORT TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICS MONITOR DSI DRAEGER MEDICAL SYSTEMS, INC. ICS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *