BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUKUDA DENSHI

    MDR report key: 1401918 · Received June 4, 2009

    Report

    Report Number
    MW5011476
    Event Type
    Injury
    Date Received
    June 4, 2009
    Date of Event
    May 29, 2009
    Report Date
    June 4, 2009
    Manufacturer
    FUKUDA DENSHI USA INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POSSIBLE DELAY IN INITIATING A CODE RESPONSE. RT WEANED PT FROM VENT 15 MINS PRIOR TO EVENT, STEPPED OUT OF ROOM AND UPON RETURN TO DRAW ABG, FOUND PATIENT UNRESPONSIVE AND BEDSIDE MONITOR WITH ALL ZEROS. NO AUDIBLE ALARMS NOTED. MAIN DESK MONITOR CHECKED AND NOTED THAT THE HEART RATE ALARM WAS OFF AND WHEN TURNED ON AT THE NURSING STATION, THE ALARM TURNED ITSELF OFF IMMEDIATELY. THIS OCCURRED MULTIPLE TIMES. FUKUDA WAS CALLED AND GUIDED THROUGH THE CONFIGURATION SETTINGS. THE PROBLEM WAS THAT THE CONFIGURATION FOR HEART RATE ALARM SOURCE WAS SET ON SPO2 AND NOT ON ECG ON THE BEDSIDE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI BEDSIDE PATIENT MONITOR DRT FUKUDA DENSHI USA INC. DS-7300

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening