BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 4454386 · Received January 23, 2015

    Report

    Report Number
    8022257-2015-00001
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    December 23, 2014
    Report Date
    December 23, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON IS CURRENTLY INVESTIGATING IN ORDER TO UNDERSTAND THE ROOT CAUSE OF THIS ISSUE. ONCE THE INVESTIGATION IS COMPLETE, MCKESSON WILL SUBMIT A F/U REPORT WITH THE EVAL SUMMARY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EMERGENCY ROOM (ER) PATIENT WAS IMAGED USING A GENERIC NAME PRIOR TO SCHEDULING THE STUDY WITH THE PT'S ACTUAL NAME RESULTING IN TWO PATIENTS IN HMI. THE TWO STUDIES WERE MERGED IN HMI USING THE WA MANAGER TOOL. IN THIS INSTANCE, MERGING OF THE SCHEDULED STUDY AND PERFORMED STUDY WAS INCOMPLETE WITH THE SCHEDULED STUDY NOT BEING REMOVED FROM THE SCHEDULED STUDIES LIST. SUBSEQUENTLY, THE ER PT WAS INADVERTENTLY SUBJECTED TO A SECOND CHEST X-RAY IMAGING PROCEDURE. THE DATE OF THIS ADVERSE EVENT AND PT INFO WERE NOT PROVIDED BY THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53633 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM.SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.9

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other