BEUDAMED
    FDA Adverse Event Other Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3216916 · Received July 8, 2013

    Report

    Report Number
    8022257-2013-00002
    Event Type
    Other
    Date Received
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY IDENTIFIED THE CAUSE OF THE ADVERSE EVENT TO BE USER ERROR. FOR THE SPECIFIC PATIENT IN QUESTION, A LARGE NUMBER OF PROCEDURES HAD ALREADY BEEN PERFORMED AT MULTIPLE FACILITIES, AND THE TOTAL LIST OF STUDIES EXCEEDED THE AVAILABLE SPACE IN THE DISPLAY WINDOW. A SCROLL BAR WAS PROVIDED ON THE DISPLAY WINDOW TO VIEW THE LIST OF STUDIES THAT EXCEEDED THE AVAILABLE SPACE IN THE DISPLAY WINDOW. THE USER DID NOT SCROLL THE LIST DOWN TO SEE THE COMPLETE LIST OF STUDIES FOR THAT PARTICULAR PATIENT, WHICH INCLUDED A CT ANGIO HEAD/NECK IMAGING PROCEDURE THAT HAD ALREADY BEEN PERFORMED AT ANOTHER LOCATION. AS A RESULT, A SECOND CT ANGIO HEAD/NECK IMAGING PROCEDURE WAS INADVERTENTLY SCHEDULED AND PERFORMED ON THE PATIENT.

    Description of Event or Problem · 1

    WHILE VISITING THE REPORTING FACILITY ON (B)(6) 2013, A MACKESSON EMPLOYEE WAS INFORMED BY A RADIOLOGIST AT THE SITE THAT A CHILD WAS INADVERTENTLY SUBJECTED TO A SECOND CT ANGIO HEAD/NECK IMAGING PROCEDURE. THE DATE OF THIS ADVERSE EVENT AND PATIENT INFORMATION WERE NOT PROVIDED BY THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311117 HORIZON MEDICAL IMAGING LLZ MCKESSON MEDICAL IMAGING COMPANY 11.8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other