BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISITE PACS

    MDR report key: 1480688 · Received July 22, 2009

    Report

    Report Number
    2954704-2009-00011
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS INC
    Product Code
    LLZ
    PMA / PMN Number
    K063267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE ISITE PACS SOFTWARE DISPLAYS CLINICAL REPORTS WITH THE STUDY PERFORMED DATE AND TIME IN GMT FORMAT, WHICH MAY NOT BE OBVIOUS TO THE END USER, WHO MAY EXPECT TO SEE THE LOCAL TIME IN THE REPORT. THIS MAY RESULT IN DISPLAYING A STUDY DATE AND TIME UP TO 12 HRS FORWARDS OR BACKWARDS IN TIME, AND IN SOME CASES MAY DISPLAY A SHIFT IN DATE UP TO ONE DAY. FURTHERMORE, IF NO IMAGES ARE ASSOCIATED TO THE REPORT, NO STUDY PERFORMED DATE/TIME STAMP WILL BE DISPLAYED. FIELD ACTION TAKEN FOR THIS ISSUE. (B)(6), RECALL AND EMERGENCY COORDINATOR, US FOOD AND DRUG ADMIN, (B)(6). CUSTOMERS WERE SENT A FIELD SAFETY NOTICE (COPY WAS PROVIDED IN ORIGINAL 806 REPORT). (B)(4). WHILE THE LOCAL EXAM DATE/TIME IS DISPLAYED IN ALL WORKLISTS AND ON THE IMAGES, THE DATE WHEN DISPLAYED IN THE CLINICAL REPORT IS PRESENTED IN GMT. (B)(4).

    Description of Event or Problem · 1

    NO REPORT OF PT HARM OR INJURY RELATED TO THIS EVENT. CUSTOMER REPORTED THAT THE EXAM DATE/TIME ON THE PRINTED REPORT IS DIFFERENT BY TWO HRS FROM THE ACTUAL EXAM DATE/TIME.

    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