BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUKUDA DENSHI

    MDR report key: 1210784 · Received October 22, 2008

    Report

    Report Number
    1210784
    Event Type
    Death
    Date Received
    October 22, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 22, 2008
    Manufacturer
    FUKUDA DENSHI USA, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND UNRESPONSIVE AND PULSELESS. TELEMETRY AND PULSE OXIMETRY DID NOT ALARM. CODE CALLED. PT ON TRACH. PRONOUNCED DECEASED AT 16:58. IT IS UNCERTAIN IF THERE WAS A MALFUNCTION OR IF IT WAS NOT ON. ECG/RESPIRATION TRANSMITTER APPROX AGE = 2005, 3 YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI ECG/RESPIRATION TRANSMITTER DSI FUKUDA DENSHI USA, INC. LX-5160

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death