BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 4155289 · Received October 7, 2014

    Report

    Report Number
    8022257-2014-00012
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON INVESTIGATED THE ISSUE AND CONCLUDED THAT (B)(4) DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT HARM. WHEN IMAGES ARE INITIALLY ACQUIRED FROM A MODALITY AND RECEIVED BY (B)(4), THE STUDY STATUS APPEARING IN THE WORK LIST IS SET TO "PERFORMED". A TECHNOLOGIST REVIEWS THE STUDY AND CHANGES THE STATUS TO "REVIEWED". REVIEWED STUDIES WILL APPEAR ON THE RADIOLOGIST STUDY LIST AND IS AVAILABLE FOR INTERPRETATION. IN THE REPORTED CASE, THE STUDY WAS PERFORMED ON (B)(6) AT 14:54:29 AND WAS "REVIEWED" APPROXIMATELY 2 HOURS LATER. THE RADIOLOGIST REPORTED THE STUDY ON (B)(6) 16:25:02.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTING FACILITY REQUESTED ASSISTANCE IN GENERATING THE AUDIT REPORT FOR A STUDY TO AID IN INVESTIGATION OF WORKFLOW DELAY FOR AN ER PATIENT. IT WAS REPORTED THAT PATIENT HARM ALLEGEDLY OCCURRED BETWEEN THE TIME THAT THE STUDY WAS PERFORMED AND THE TIME IT WAS REVIEWED. THE EXTENT OF THE HARM WAS NOT COMMUNICATED TO MCKESSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626203 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM.SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.0.8

    Patients

    Seq Age Sex Outcome Treatment
    1 UKN Other