BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAC

    MDR report key: 10726400 · Received October 23, 2020

    Report

    Report Number
    10726400
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 7, 2020
    Report Date
    October 14, 2020
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DPS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RENAL REPLACEMENT THERAPY, ELECTROCARDIOGRAM (EKG) WAS ORDERED. WHEN PATIENT BARCODE WAS SCANNED WITH EKG MACHINE, BARCODE DID NOT READ PROPERLY. EKG WAS OBTAINED UNDER PREVIOUS PATIENT'S MEDICAL RECORD NUMBER SAVED IN EKG MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195234 MAC ELECTROCARDIOGRAPH DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening