BEUDAMED
    FDA Adverse Event Death Summary report: N

    90478 TELEMETRY MODULE

    MDR report key: 489609 · Received October 8, 2003

    Report

    Report Number
    3023361-2003-00002
    Event Type
    Death
    Date Received
    October 8, 2003
    Date of Event
    August 13, 2003
    Report Date
    October 7, 2003
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT WENT INTO VENTRICULAR FIBRILLATION AND UNIT DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90478 TELEMETRY MODULE TELEMETRY MODULE DSI DATEX-OHMEDA, INC. 90478 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death