BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRICITY

    MDR report key: 3913670 · Received June 30, 2014

    Report

    Report Number
    MW5037054
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    OUG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CRITICALLY ILL PT UNDER WENT RADIOGRAPHIC EVAL OF CHEST AND ABDOMEN. THE LAST NAME OF THE PT CONTAINED ONE APOSTROPHE. THE RADIOGRAPH IMAGES COULD NOT BE ACCESSED ON THE EHR RESULTS MDDS. IT WAS DETERMINED THAT THE ONE ENTERING THE PT'S NAME AT THE IMAGING VENDOR ENTERED A DOUBLE APOSTROPHE, RATHER THAN ONE. IT COULD NOT BE CORRECTED FOR DAYS, ONCE THE IMAGES WERE FOUND, 5 DAYS AFTER THEY WERE DONE. IT TOOK ANOTHER 3 DAYS FOR PACS VENDOR TO CORRECT THIS MISIDENTIFICATION ISSUE. THE VENDOR'S DEVICE IS DEFECTIVE BECAUSE IT ALLOWED ABSURDITY (THERE IS NEVER A NAME WITH CONSECUTIVE APOSTROPHES) AND IT FAILED TO WARN OF THE ERROR. THESE MDDS DEVICES NEED TIGHTER REGULATION, SURVEILLANCE, AND SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378915 CENTRICITY MDDS PACS OUG GENERAL ELECTRIC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR