BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUKUDA DENSHI

    MDR report key: 308054 · Received December 5, 2000

    Report

    Report Number
    9611031-2000-00005
    Event Type
    Death
    Date Received
    December 5, 2000
    Date of Event
    October 25, 2000
    Report Date
    November 7, 2000
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CARDIOPULMONARY ARREST OCCURRED FOLLOWING PROGRESSIVE SUSTAINED BRADYCARDIA OVER A PERIOD OF 17 MINUTES FROM ONSET OF ARRHYTHMIA. THE BASELINE RHYTHM PRIOR TO THE EVENT WAS CHRONIC ATRIAL FIBRILLATION. THE FUKUDA DENSHI MONITOR FAILED TO ALARM OR PRODUCE AN AUTOMATED STRIP DURING THE EVENT. FURTHER INVESTIGATION OF THE EQUIPMENT ONSITE BY THE MANUFACTURER REVEALED THAT THE ARRHYTHMIA ALARMS INCLUDING ASYSTOLE ALARM HAD BEEN TURNED TO THE OFF POSITION. THE EVENT OCCURRED AT THE CHANGE OF SHIFT. WHEN THE MONITOR TECH OBSERVED AN AGONAL RHYTHM AT THE NURSES STATION MONITOR TECH DEPRESSED THE MANUAL BUTTON TO PRODUCE AN EVENT HISTORY CREATING AN 8 SECOND STRIP INDICATING THE TIME OF ONSET. THERE WERE SEVERAL REPEATED DEPRESSIONS OF THE BUTTON TO PRODUCE A STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI TELEMETRY CENTRAL STATION DSI FUKUDA DENSHI CO., LTD. DS-5800NX *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death