BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC EHR

    MDR report key: 6636342 · Received June 10, 2017

    Report

    Report Number
    MW5070360
    Event Type
    Injury
    Date Received
    June 10, 2017
    Date of Event
    June 9, 2017
    Report Date
    June 10, 2017
    Manufacturer
    EPIC
    Product Code
    JQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO EMERGENCY WARD WITH DELIRIUM AND LEUKOCYTOSIS. EXTENSIVE NEUROLOGICAL EVAL WAS UNDERTAKEN. IT WAS NEGATIVE. THE CHEST RADIOGRAPH WITH REPORTED LATE, AND THE REPORT CAME BACK SILENTLY INTO THE RADIOGRAPH SILO, AS PNEUMONIA, BUT NO ONE SAW THE REPORT. THERE WAS NOT ANY NOTICE OR WARNING THAT A NEW REPORT HAD BEEN GENERATED. IN ADDITION, THE EHR DEVICE USES ELABORATE SYSTEM TO GENERATE A COMPLETE HISTORY AND PHYSICAL EXAM REPORT. THERE WAS NO WAY THAT THE LUNGS WERE "CLEAR" AS STATED BY THE DOCTORS (ER AND ATTENDING) USING THE CANNED LANGUAGE OF THE EHR MACRO/TEMPLATE WHEN THE PT HAD BILATERAL PNEUMONIA. THE TREATMENT WITH ANTIBIOTICS WAS DELAYED BY 20 HOURS. THIS CASE RAISES IMPORTANT ISSUES THAT HAVE BEEN WROUGHT BY EHR DEVICES THAT HAVE NOT HAD ANY VETTING FOR SAFETY, UNSTABILITY, AND EFFICACY, AND REMAIN FREE OF AFTER MARKET SURVEILLANCE. REPORTS OF ALL TYPES GET DEPOSITED INTO THEIR RESPECTIVE SILOS SILENTLY, AND NO ONE KNOWS THE RESULTS FOR HOURS WHETHER THEY ARE GOOD OR BAD. CARE IS DELAYED WITH FREQUENT LIFE THREATENING CONSEQUENCES. THE EHR DEVICE ENABLES ELABORATE REPORTS OF EXAMINATIONS, THAT OFTEN ARE NOT DONE, WITH ONE SWIFT CLICK OF THE MOUSE. BASICALLY, THESE ARE FAKE EXAMS AND HISTORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413508 EPIC EHR SOFTWARE JQP EPIC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening