BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON MEDICAL IMAGING

    MDR report key: 3940080 · Received June 19, 2014

    Report

    Report Number
    8022257-2014-00006
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. FURTHERMORE, DURING THE INVESTIGATION THE REPORTING FACILITY STATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEMISE OF THE PATIENT. WHEN IMAGES ARE INITIALLY ACQUIRED FROM A MODALITY AND RECEIVED BY HMI, THE STUDY STATUS APPEARING IN THE WORK LIST IS SET TO "PERFORMED". A TECHNOLOGIST REVIEWS THE STUDY AND CHANGES THE STATUS TO "REVIEWED". WHEN THE STATUS HAS BEEN CHANGED TO "REVIEWED", THE STUDY WILL APPEAR ON THE RADIOLOGIST STUDY LIST AND IS AVAILABLE FOR INTERPRETATION. IF ADDITIONAL IMAGES ARE SUBSEQUENTLY ACQUIRED FROM THE MODALITY, THE WORK LIST STUDY STATUS AUTOMATICALLY REVERTS BACK TO "PERFORMED". A TECHNOLOGIST MUST THEN REVIEW THE NEW IMAGES INCLUDED IN THE STUDY, AND CHANGE THE STATUS BACK TO "REVIEWED" TO ENSURE THE STUDY REAPPEARS ON RADIOLOGIST STUDY LIST FOR INTERPRETATION. BASED UPON REVIEW OF THE APPLICATION LOGS, THE STUDY WAS SENT FROM THE IMAGING MODALITY ON (B)(6) 2014, AT 11:51 AM. THE TECHNOLOGIST REVIEWED THE STUDY AND CHANGED THE STATUS TO "REVIEWED" ON (B)(6) 2014, AT 11:56 AM. ADDITIONAL IMAGES FOR THAT STUDY WERE SENT FROM THE MODALITY TO HMI ON (B)(6) 2014, AT 12:10 PM AND THE STUDY STATUS AUTOMATICALLY REVERTED BACK TO "PERFORMED", AS DESIGNED. THE STUDY STATUS WAS MARKED BY A TECHNOLOGIST AS "REVIEWED" AGAIN ON (B)(6) AND A PRELIMINARY REPORT WAS CREATED. THE STUDY STATUS WAS MARKED BY THE RADIOLOGY RESIDENT AS "NEEDS OVER READ" ON (B)(6) 2014. THE FINAL INTERPRETATION REPORT WAS CREATED ON (B)(6) BY THE RADIOLOGIST, DURING WHICH TIME IT WAS LEARNED THAT THE PT HAD EXPIRED.

    Description of Event or Problem · 1

    MCKESSON RECEIVED A REQUEST FROM THE REPORTING FACILITY TO INVESTIGATE WHY A STAT CT CHEST ABDOMEN PELVIS STUDY PERFORMED FOR AN ER PATIENT DID NOT APPEAR ON THE RADIOLOGIST STUDY LIST FOR INTERPRETATION FOR MORE THAN 7 DAYS. IT WAS REPORTED THAT PT DIED BETWEEN DATE THE STUDY WAS PERFORMED AND THE DATE THE STUDY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359791 HORIZON MEDICAL IMAGING PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 11.9

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death