BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISITE PACS

    MDR report key: 2160618 · Received July 6, 2011

    Report

    Report Number
    2954704-2011-00007
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 7, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PHILIPS BECAME AWARE OF THIS INCIDENT ON (B)(6), 2011. A DELAY IN PATIENT CARE WAS DUE TO IMAGES NOT BEING AVAILABLE ON THE PRODUCTION ISITE PACS WHEN A HEAD TRAUMA CASE CAME INTO A&E IN THE MIDDLE OF THE NIGHT. THE IMAGES WERE TAKEN, SENT TO ISITE PACS AND A MESSAGE WAS SENT TO THE RADIOLOGIST TO REVIEW THE IMAGES. BECAUSE HE COULD NOT OPEN OR SEE THE IMAGES AND HE HAD TO COME INTO THE (B)(4) DEPARTMENT TO REVIEW, THIS CAUSED A DELAY IN PATIENT CARE. INVESTIGATION OF PATIENT INFORMATION/OUTCOME HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS ISITE PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1