BEUDAMED
    FDA Adverse Event Death Summary report: N

    DASH 4000 MONITOR

    MDR report key: 10178512 · Received June 19, 2020

    Report

    Report Number
    MW5095087
    Event Type
    Death
    Date Received
    June 19, 2020
    Date of Event
    June 18, 2020
    Report Date
    June 18, 2020
    Manufacturer
    GENERAL ELECTRIC HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED IN EMERGENCY DEPARTMENT FOR EVALUATION AND TREATMENT OF ABDOMINAL PAIN AND ELEVATED BLOOD PRESSURE. DURING A ROUTINE CHECK, ASYSTOLE WAS WITNESSED ON THE CARDIAC MONITOR AS THE NURSE ENTERED THE ROOM. CPR WAS IMMEDIATELY IMPLEMENTED. THE MONITOR WAS VISUALLY WORKING HOWEVER, NO ALARMS WERE AUDIBLY ALERTING THE NURSING STAFF OF A CARDIAC EVENT. VOLUME SETTINGS ON THE MONITOR WERE ON AND TURNED UP TO 50% BUT NO SOUND WAS HEARD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636954 DASH 4000 MONITOR MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX GENERAL ELECTRIC HEALTHCARE / GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC REF2035598

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death