BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIC ESCRIBE

    MDR report key: 11840931 · Received May 18, 2021

    Report

    Report Number
    11840931
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 12, 2021
    Manufacturer
    EPIC SYSTEMS CORPORATION
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED WITH CONCERNS REGARDING HIS MEDICAL RECORDS INFORMATION CROSSING OVER WITH ANOTHER PATIENT WITH SIMILAR NAME, SAME DATE OF BIRTH, AND BOTH PATIENT¿S LIVE IN SAME TOWN. THIS IS A POSSIBLE BREACH OF PHI (PROTECTED HEALTH INFORMATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737090 EPIC ESCRIBE MEDICAL DEVICE DATA SYSTEM OUG EPIC SYSTEMS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1