BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA1000

    MDR report key: 1234061 · Received November 4, 2008

    Report

    Report Number
    3004526608-2008-00093
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Removal / Correction Number
    3004526608-08/29/08-007-
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GE HEALTHCARE INTEGRATED IT SOLUTIONS BARRINGTON SITE HAS BEEN UNDERTAKING A NUMBER OF QUALITY IMPROVEMENT ACTIVITIES OVER THE LAST SEVERAL MONTHS. AS PART OF THESE ACTIVITIES, WE HAVE UPDATED THE RISK ASSESSMENT CONTROL RECORD. THE UPDATE HAS RESULTED IN THE ASSESSMENT THAT THIS REPORTED MALFUNCTION NO LONGER MEETS THE REPORTABILITY CRITERIA AS OUTLINED IN THE RISK ASSESSMENT CONTROL RECORD FOR GE HEALTHCARE. GE REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS DUPLICATED THROUGH INTERNAL INVESTIGATION. IT WAS FOUND THAT THE PACS SYSTEM DOES PROVIDE THE USER WITH A NOTICE IN THE JACKET HEADER THAT THE JACKET DOES NOT MATCH THE CURRENT EXAM WHEN AN INCORRECT PATIENT JACKET APPEARS. THE PATIENT JACKET, ALTHOUGH NOT MATCH WITH THE CURRENT EXAM DOES PROVIDE THE CORRECT INFO TO THE USER ABOUT IT'S CONTENTS, INCLUDING THE PT'S NAME AND IDENTIFIER. THE CONTENTS IF SELECTED MATCH THE PT JACKET AND DISPLAY THE SAME NAME AND ID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN RA1000 DIAGNOSTIC PACS WORKSTATION WHEN VIEWING AN EXAM IN THE DICTATE MODE AND THEN SWITCHING TO THE BROWSE MODE, THE MOST RECENTLY VIEWED EXAM IN BROWSE MODE IS DISPLAYED INSTEAD OF THE SELECTED EXAM. THERE IS A CONCERN THAT THE MOST RECENT EXAM COULD APPEAR SIMILAR TO THE EXPECTED EXAM AND RESULT IN A MISDIAGNOSIS OR INCORRECT TREATMENT. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32550 CENTRICITY RA1000 PICTURE ARCHIVING AND COMMUNICATION SYS LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown