BEUDAMED
    FDA Adverse Event Death Summary report: N

    FUKUDA DENSHI MODEL LX-3100

    MDR report key: 305241 · Received November 15, 2000

    Report

    Report Number
    9611031-2000-00004
    Event Type
    Death
    Date Received
    November 15, 2000
    Date of Event
    August 13, 2000
    Report Date
    November 13, 2000
    Manufacturer
    FUKUDA DENSHI CO., LTD.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RENTED TELEMETRY UNIT PICKED UP LOTS OF INTERFERENCE. WHEN NURSE WENT TO CHECK ON PT, PT FOUND UNCONSCIOUS, WITH NO PULSE. CODED, BUT TO NO AVAIL. EQUIPMENT FAILED TO NOTIFY STAFF OF ABNORMAL OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUKUDA DENSHI MODEL LX-3100 TELEMETRY TRANSMITTER DSI FUKUDA DENSHI CO., LTD. LX-3100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death