BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISITE PACS

    MDR report key: 1848415 · Received September 22, 2010

    Report

    Report Number
    2954704-2010-00011
    Event Type
    Death
    Date Received
    September 22, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 24, 2010
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. PHILIPS IS ABLE TO EVALUATE THE PRODUCT AT THE CUSTOMER SITE BY REMOTE ACCESS, AS WELL AS EVALUATE THE SAME PRODUCT VERSION IN-HOUSE. BASED ON THE AVAILABLE INFO AT THE TIME OF THIS REPORT AND THE UPDATE OBTAINED FROM THE CUSTOMER / USER FACILITY, WE CAN CONFIRM THAT ISITE PACS DID NOT CONTRIBUTE TO THE DEATH OF THE PT.

    Description of Event or Problem · 1

    ON SEPT 15TH 2010, AN ISITE PACS CUSTOMER FACILITY REPORTED THAT THEY HAD A PT DEATH ON (B)(6) 2010, "WITH A LUNG PROBLEM". THE IMAGE TAKEN FROM THAT PT DID NOT COME TO ISITE PACS "AT THAT MOMENT" AND THE PT DIED. THE REASON FOR THE DEATH AND VERIFICATION WHETHER ISITE PACS IN ANY WAY CONTRIBUTED TO THE DEATH WAS STILL UNDER INVESTIGATION AND NEEDED TO BE CONFIRMED BY THE CUSTOMER. ON SEPT 19TH, FURTHER UPDATE WAS RECEIVED FROM THE FACILITY CONFIRMING THAT ISITE PACS DID NOT CONTRIBUTE IN THE CAUSE OF PT'S DEATH. THE PERSON AT THE FACILITY TAKING THE IMAGE MADE A MISTAKE IN THE RADIOLOGY INFO SYSTEM (RIS), A SOFTWARE SYSTEM INDEPENDENT OF ISITE PACS, THEREFORE, THE STATUS OF THE IMAGE WAS INCORRECT AND DID NOT COME ON THE WORKLIST OF THE RADIOLOGIST AND THE WRONG CONCLUSION WAS DRAWN. ISITE PACS DID NOT MALFUNCTION NOR CONTRIBUTE TO THE REPORTED DEATH. INFO ON THE PT AND CAUSE OF DEATH HAS BEEN REQUESTED FROM THE FACILITY HOWEVER, NO FURTHER INFO HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISITE PACS ISITE PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death