BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROCARDIOGRAPH

    MDR report key: 5784850 · Received July 12, 2016

    Report

    Report Number
    5784850
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    April 19, 2016
    Report Date
    June 10, 2016
    Manufacturer
    GE MEDICAL INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EKG MONITOR/CABLES WERE NOT WORKING. THE PATIENT WAS WITH NO EKG FOR OVER AN HOUR. AFTER SWITCHING BETWEEN WIRES, CABLES, AND MONITORS, WE CONCLUDED THAT THE EKG WIRES, THE EKG CABLE AND THE MONITOR ITSELF ALL MALFUNCTIONED. ALL THREE HAD TO BE CHANGED TOGETHER TO GET A FUNCTIONAL EKG. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438467 ELECTROCARDIOGRAPH DPS GE MEDICAL INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO