BEUDAMED
    FDA Adverse Event Death Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 4800998 · Received May 26, 2015

    Report

    Report Number
    8022257-2015-00004
    Event Type
    Death
    Date Received
    May 26, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PRELIMINARY REPORT HAD BEEN CREATED, MODIFIED, OR ACCESSED BASED ON INFO CONTAINED IN APPLICATION LOGS. DURING FURTHER DISCUSSIONS WITH THE REPORTING FACILITY TO CLARIFY THE SPECIFIC INFO BEING REQUESTED, AND ANALYSIS OF APPLICATION LOGS, MCKESSON'S INVESTIGATION CONCLUDED THE FOLLOWING: A PRELIMINARY REPORT WAS CREATED ON (B)(6) 2015 BY A RADIOLOGIST. UPON FURTHER REVIEW OF THE PATIENT'S CONDITION BY ANOTHER RADIOLOGIST ON-CALL THE FOLLOWING DAY, THE PATIENT UNDERWENT ABDOMINAL SURGERY ON (B)(6) 2015. THE REPORTING FACILITY INDICATED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS POST-SURGERY AND EXPIRED ON (B)(6) 2015. 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

    ON (B)(6) 2015 MCKESSON SUPPORT RECEIVED A REQUEST FROM THE CUSTOMER TO PROVIDE ASSISTANCE WITH AN INVESTIGATION INTO THE CHANGE HISTORY FOR A PRELIMINARY REPORT ATTACHED TO A CT STUDY FOR A PATIENT. DURING A F/U DISCUSSION WITH THE REPORTING FACILITY ON 04/23/2015, MCKESSON BECAME AWARE THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO COMPLICATIONS FOLLOWING ABDOMINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339081 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death