BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISITE PACS

    MDR report key: 1728668 · Received June 9, 2010

    Report

    Report Number
    2954704-2010-00006
    Event Type
    Other
    Date Received
    June 9, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 1, 2006
    Manufacturer
    PHILIPS HEALTHCARE INC.
    Product Code
    LLZ
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 INFORMATION 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 INFORMATION REGARDING THIS ISSUE AND THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DICTATION WAS MADE TO AN INCORRECT PT. THEY IDENTIFIED THAT OCCASIONALLY WHEN USING A THIRD PARTY DICTATION DEVICE WITH ISITE PACS, THE PT DISPLAYED IN THE DICTATION DEVICE REPORT LIST IS DIFFERENT THAN THE PT DISPLAYED IN ISITE PACS. THE PT INFORMATION IN EACH APPLICATION IS CORRECT FOR THAT APPLICATION. THE IMAGES IN ISITE PACS ARE CORRECTLY LABELED. THE DOCTOR DETECTED THE MISMATCH BEFORE THE INCORRECT DICTATION WAS COMPLETE AND THE REPORT WAS NEVER SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1