BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL DEVICE DATA SYSTEM

    MDR report key: 20160186 · Received September 5, 2024

    Report

    Report Number
    MW5159278
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    March 13, 2024
    Report Date
    August 31, 2024
    Manufacturer
    EPIC SYSTEMS CORPORATION.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I SENT A NOTE FROM (B)(6), MY ELECTRONIC MEDICAL RECORD, TO ANOTHER DOCTOR. MY NOTE CANNOT BE SEEN IN (B)(6). THIS RESULTED IN A FAILURE TO DIAGNOSE A PATIENT, A REPEATED SPINAL TAP, AND DELAY IN CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536387 MEDICAL DEVICE DATA SYSTEM MEDICAL DEVICE DATA SYSTEM OUG EPIC SYSTEMS CORPORATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other