BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISITE PACS 3.X

    MDR report key: 3259927 · Received July 24, 2013

    Report

    Report Number
    2954704-2013-00003
    Event Type
    Death
    Date Received
    July 24, 2013
    Report Date
    July 4, 2013
    Manufacturer
    PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Description of Event or Problem · 1

    PHILIPS RECEIVED NOTIFICATION FROM A USER FACILITY THAT A DELAY IN THE ABILITY TO MARK EXAMS AS READ IN ISITE PACS WAS NOT DIRECTLY RELATED BUT MAY HAVE CONTRIBUTED TO A PATIENT DEATH. ON (B)(6) 2013, THE USER FACILITY RADIOLOGIST WAS UNABLE TO MARK EXAMS AS READ, WHICH COULD POSSIBLY HAVE DECREASED THE LENGTH OF THE WORKLIST. IT WAS STATED BY A REPRESENTATIVE OF THE USER FACILITY THAT THE RADIOLOGIST HAD OVER FOUR PAGES OF EXAMS TO READ. THE RADIOLOGIST WAS WORKING ON READING EXAMS FROM THE WORK LIST IN ALPHABETICAL ORDER WHERE ISITE PACS IS SET-UP TO DISPLAY STUDY DATE BY DEFAULT. THE PATIENT'S STUDY WAS ACQUIRED AT APPROXIMATELY 3 PM ON (B)(6). THE PATIENT'S LAST NAME STARTED WITH THE LETTER "(B)(6)", IT WAS NEAR THE BOTTOM OF THE LIST AND WAS NOT REVIEWED THAT DAY. ON (B)(6) 2013, THE EXAM WAS READ BY A DIFFERENT RADIOLOGIST. IT WAS REPORTED THAT THE PATIENT'S DEATH WAS APPROXIMATELY A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346122 ISITE PACS 3.X LLZ PHILIPS HEALTHCARE ENTERPRISE IMAGING INFORMATICS 835013

    Patients

    Seq Age Sex Outcome Treatment
    1 Death