BEUDAMED
    FDA Adverse Event Death Summary report: N

    DASH 4000

    MDR report key: 6263184 · Received January 19, 2017

    Report

    Report Number
    6263184
    Event Type
    Death
    Date Received
    January 19, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 18, 2017
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE HOSPITAL VISIT, THE PATIENT'S HEART RATE WAS PRIMARILY RUNNING AROUND 50-70 BEATS PER MINUTE WITH TWO INCIDENTS OF 80 TO 92. BLOOD PRESSURE WAS CLOSE TO 100/50 CONSISTENTLY (NURSING NOTE DOCUMENTED AT 1054): THE PATIENT WAS ALERT AND ORIENTED TO PERSON, PLACE AND TIME, THE PATIENT IS ON 2 LITERS/MINUTE OF OXYGEN VIA NASAL CANNULA. THE PATIENT IS ALSO ON CONTACT PRECAUTIONS, HAD LOOSE STOOL, AND THEIR CLOSTRIDIUM DIFFICILE TEST CAME BACK POSITIVE. THE PATIENT WAS MOVED TO ANOTHER ROOM. THE PATIENT HAD AN ELEVATED HR AND THE PROVIDER WAS CONTACTED AND MEDICATED PER THE RECORD. THE PATIENT WENT TO DIALYSIS, WITH DASH FOR TELEMETRY AND HEART RATE MONITORING. AT 0647 LOPRESSOR IV 2.5MG ORDERED. AT 0658 LOPRESSOR IV 2.5MG ADMINISTERED. AT 0743 HEART RATE 135, BLOOD PRESSURE 77/51. AT 0821 ROUTINELY SCHEDULED LOPRESSOR 25MG BY MOUTH TWICE PER DAY ADMINISTERED. CONTINUOUS HEPARIN DRIP RUNNING AT 14 UNITS/KG/HR. AT 1036: DIALYSIS INITIATED IN INPATIENT DIALYSIS. HEART RATE CONTINUED TO SLOWLY TREND DOWN WITH LOWEST RESULT AT 1210. HEART RATE = 97 BUT UP TO 126 AT 1241. ARRHYTHMIA ALARM PREVIOUSLY TURNED OFF/NOT ALARMING WITH CARDIAC ARRHYTHMIA. PT IN V-TACH FOLLOWED BY ASYSTOLE - ARRHYTHMIA ALARM ON TELEMETRY MONITOR NOT SOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48478 DASH 4000 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. DASH4000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death DIALYSIS