BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOARIAN

    MDR report key: 3829996 · Received May 19, 2014

    Report

    Report Number
    MW5036202
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 17, 2014
    Manufacturer
    SIEMENS
    Product Code
    NSX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO HOSPITAL WITH CHEST PAIN. CARDIAC ENZYME TESTS WERE ORDERED TO RULE OUT MYOCARDIAL INFARCTION. CPK AND ISOENZYME MB CAME BACK IN TO THE EHR, BUT NO ONE KNEW THEY WERE THERE. THEY WERE POSITIVE FOR HEART ATTACK FOR TREATMENT WAS DELAYED BECAUSE OF THE DELAY IN GETTING THE RESULTS, THAT WERE ON THE EHR FOR SEVERAL HOURS. THE DESIGN OF THE EHR IS FLAWED TO NOT HAVE A WARNING THAT CRITICAL LIFE THREATENING RESULTS CAME BACK FROM THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295645 SOARIAN NSX SIEMENS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening