BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINDRAY

    MDR report key: 3972877 · Received July 16, 2014

    Report

    Report Number
    3972877
    Event Type
    Death
    Date Received
    July 16, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MINDRAY N. A.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED 11 MINUTES OF A PERSISTENT LIFE-THREATENING EPISODE OF BRADYCARDIA. THE MONITOR IDENTIFIED BRADYCARDIA WITH AN ALARM FOLLOWED BY A CONTINUED PERIOD OF BRADYCARDIA FOR APPROX 11 MINUTES DURING WHICH NO ARRHYTHMIA WAS IDENTIFIED OR ALARMED. AT THE END OF THIS 11 MINUTES PERIOD OF BRADYCARDIA WITH NO ALARMS, THE MONITOR AGAIN ALARMED FOR BRADYCARDIA FOLLOWED IMMEDIATELY BY A FALSE ALARM FOR V-TACH THAT OCCURRED WHEN CPR WAS INITIATED AS PT WAS FOUND UNRESPONSIVE. PT WAS TRANSFERRED TO CORONARY ICU. APPROX 3 HOURS LATER, PT CODED. PT DIED APPROX 6 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415874 MINDRAY CENTRAL STATION MHX MINDRAY N. A. PANORAMA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R