BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNRISE

    MDR report key: 3807187 · Received May 8, 2014

    Report

    Report Number
    MW5036061
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ALLSCRIPTS
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMMUNICATIONS IN THIS HOSPITAL THAT HAS DEPLOYED CPOE AND EHR SYSTEMS HAVE BEEN HAMPERED EVER SINCE FOR INNUMERABLE REASONS, MOST SIGNIFICANTLY THE USER UNFRIENDLINESS OF THE CPOE AND EHR DEVICES. THE PATIENT WHO SUSTAINED INJURY WAS AT RISK FOR RESPIRATORY ARREST DUE TO A NARROWING IN THE TRACHEA. THERE IS NO PLACE ON THE EHR TO LIST SUCH A LIFE THREATENING CONDITION THAT WOULD BE VISIBLE TO EACH AND EVERY CARE TEAM MEMBER WHO OPENED THE EHR FOR THIS PATIENT. THE LACK OF COMMUNICATION BREEDS UNFAMILIARITY WITH THE SPEED AT WHICH THE PATIENT COULD DETERIORATE, IN ADDITION TO THE INTRINSIC DELAY IN GETTING TREATMENTS ORDERED BY THE CPOE SYSTEM. IT HAS BEEN REPORTED THAT PATIENTS ARE NEGLECTED WHEN THE NURSE AND CARE TEAM MEMBERS FOCUS ON THE COMPUTERS RATHER THAN THE PATIENTS, SOMETHING THAT IS COMMONPLACE CONSIDERING THE POOR USABILITY OF THE EHRS. THE PT IN QUESTION DEVELOPED ACUTE RESPIRATORY DISTRESS. CARE WAS DELAYED DUE TO THE ABOVE MENTIONED REASONS. THE PT SUSTAINED A COMPLETE RESPIRATORY ARREST THAT LED TO A CARDIAC ARREST AND ANOXIC BRAIN INJURY. THE EHR DEVICE IS DEFECTIVE IN THAT IT FAILS TO ENABLE EXPEDIENT COMMUNICATION OF THE CRITICAL LIFE THREATENING PROBLEMS OF EVERY PATIENT WHICH CAUSES NEGLECT AND DELAYS IN CARE WHEN LIFE IS ON THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278309 SUNRISE CPOE/EHR NSX ALLSCRIPTS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R| S