BEUDAMED
    FDA Adverse Event Death Summary report: N

    VUE PACS

    MDR report key: 3151900 · Received June 5, 2013

    Report

    Report Number
    1315356-2013-00006
    Event Type
    Death
    Date Received
    June 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 5, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K083673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH IS CURRENTLY INVESTIGATING THIS ISSUE TO DETERMINE IF THE VUE PACS CONTRIBUTED TO THE ADVERSE EVENT. IT APPEARS THAT THE PT CAME IN AND WAS ASSIGNED A NEW MEDICAL RECORD NUMBER AS IF HE WAS A NEW PT. CD IMPORT CT IMAGES WERE ASSIGNED TO THE NEW MEDICAL RECORD NUMBER. UNK TO THE TECHNICIAN AT THE TIME, THERE HAS BEEN AN EXISTING MEDICAL RECORD NUMBER WITH PRIOR STUDIES FROM 2008 ALREADY IN THE SYSTEM. A MERGE PROCESS WAS CARRIED OUT TO MERGE THE TWO (2) MEDICAL RECORDS FOR THE PT SO THAT THE IMAGES WERE EVENTUALLY AVAILABLE. THE RADIOLOGIST WAS ABLE TO READ THE IMAGES FOR THE SURGEON.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CARESTREAM HEALTH RECEIVED A REPORT OF A 5 YEAR OLD PASSING AWAY IN THE OPERATING ROOM. CARESTREAM WAS INFORMED THAT CT IMAGES WERE UNAVAILABLE FOR THE CHILD WHILE THE CHILD WAS IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248066 VUE PACS PACS LLZ CARESTREAM HEALTH, INC. VUE PACS

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death