BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC 5500

    MDR report key: 4972899 · Received July 2, 2015

    Report

    Report Number
    4972899
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    May 16, 2015
    Report Date
    July 2, 2015
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE PT. NEEDS AN ECG AFTER SOTALOL MEDICATION. WE PLACED THE ORDER IN (B)(6) BUT IT WILL NOT UPLOAD INTO THE ECG MACHINE. WE TRIED BOTH MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431551 MAC 5500 ELECTROCARDIOGRAPH DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 5500 *
    431552 MAC 5500 ELECTROCARDIOGRAPH DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 5500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR