BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 5040335 · Received August 28, 2015

    Report

    Report Number
    8022257-2015-00005
    Event Type
    Death
    Date Received
    August 28, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 5, 2015
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO THE REQUEST FROM THE REPORTING FACILITY, MCKESSON INITIATED AN INVESTIGATION IN ORDER TO DETERMINE WHEN THE NM STUDY WAS REVIEWED BY THE TECHNOLOGIST. MCKESSON INVESTIGATION OF THE SYSTEM LOGS INDICATE THAT THE NM STUDY PERFORMED ON (B)(6) 2015 AT 18:10 WAS MARKED AS REVIEWED BY THE TECHNOLOGIST ON (B)(6) 2015 AT 10:13. THE NM STUDY WAS REPORTED BY A RADIOLOGIST ON (B)(6) 2015 AT 13:05. BASED ON THE INVESTIGATION PERFORMED AND ANALYSIS OF THE APPLICATION LOGS, THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER SITE THAT ON (B)(6) 2015, A PATIENT WAS IMAGED FOR A NUCLEAR MEDICINE (NM) STUDY AT 18:10. THE PATIENT EXPIRED ON (B)(6) 2015 AT 21:50. ON (B)(6) 2015, THE CUSTOMER SITE CLINICAL IMAGING ADMINISTRATOR CONTACTED MCKESSON REQUESTING ASSISTANCE, IN DETERMINING,THROUGH THE REVIEW OF THE PACS LOGS, THE DATE AND TIME THE NM STUDY WAS REVIEWED BY THE PERFORMING TECHNOLOGIST AND MOVED TO THE RADIOLOGIST'S WORKLIST FOR DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571296 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMMUNICATION SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.9

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death