BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1671185 · Received April 26, 2010

    Report

    Report Number
    2954704-2010-00003
    Event Type
    Other
    Date Received
    April 26, 2010
    Date of Event
    January 28, 2010
    Report Date
    April 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISITE PACS IS A SOFTWARE PRODUCT. WE ARE 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, WE CANNOT CONFIRM THAT THE DEVICE WAS A FACTOR IN THE INCIDENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(4) 2010, THE CUSTOMER CALLED AND REQUESTED INFO FOR THIRD PARTY MODALITY VENDOR SIEMENS REGARDING SUPPORTED DICOM TAGS ON ISITE PACS. AFTER CONFIRMING SUPPORT OF THE IDENTIFIED DICOM TAG, THE TICKET WAS CLOSED. ON (B)(4) 2010, THE TICKET WAS REOPENED. THIS WAS BELIEVED TO BE A THIRD PARTY MODALITY VENDOR ISSUE THAT RESULTED IN REQUESTING THE CUSTOMER TO CONTACT SIEMENS TO REVIEW THE MODALITY CONFIGURATION. NO RESPONSE WAS RECEIVED BY THE CUSTOMER FROM SIEMENS AND TICKET CLOSED FOR THE SECOND TIME. ON (B)(4) 2010, THE CUSTOMER CALLED AND REQUESTED TO REOPEN THE INVESTIGATION. AT THIS TIME, THE CUSTOMER IDENTIFIED THAT INFO IN THE DICOM 6000 TAGS FROM SIEMENS MODALITIES WERE NOT DISPLAYING WHEN MULTI-FRAME IMAGES WERE VIEWED IN ISITE PACS. THE ISSUE WAS MARKED A COMPLAINT AND ESCALATED FOR REVIEW.

    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