BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEMETRY MONITORING EQUIPMENT AND SOFTWARE

    MDR report key: 513624 · Received March 2, 2004

    Report

    Report Number
    513624
    Event Type
    Death
    Date Received
    March 2, 2004
    Date of Event
    December 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    GYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WENT INTO BRADYCARDIA AND HEART RATE WAS LESS THAN 50, THE TELEMETRY BEEPER DID NOT ALERT THE RUN TO THE PT DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELEMETRY MONITORING EQUIPMENT AND SOFTWARE TELEMETRY MONITORING EQUIPMENT GYE GENERAL ELECTRIC MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death