BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 4135169 · Received September 25, 2014

    Report

    Report Number
    8022257-2014-00010
    Event Type
    Death
    Date Received
    September 25, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL IMAGING COMPANY COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE HORIZON MEDICAL IMAGING (HMI) SYSTEM PERFORMED AS DESIGNED AND NO MALFUNCTION OF THE DEVICE OCCURRED.

    Description of Event or Problem · 1

    THE REPORTING FACILITY CONTACTED MCKESSON TO REQUEST ASSISTANCE WITH AN INVESTIGATION INTO SLOW TRANSFER OF IMAGES FROM MODALITIES CONNECTED TO MCKESSON RADIOLOGY PACS. THE REPORTING FACILITY ALLEGED A TRAUMA PATIENT WAS TRANSFERRED TO ANOTHER FACILITY, DUE TO A DELAY IN AVAILABILITY OF A STUDY FOR THE PATIENT. THE PATIENT EXPIRED DURING TRANSIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596617 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death