BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA1000

    MDR report key: 1160642 · Received September 1, 2008

    Report

    Report Number
    3004526608-2008-00070
    Event Type
    Malfunction
    Date Received
    September 1, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 7, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Removal / Correction Number
    3004526608-08/29/08-007-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 MATCHED WITH THE CURRENT EXAM, DOES PROVIDE THE CORRECT INFORMATION TO THE USER ABOUT ITS CONTENTS, INCLUDING THE PATIENT NAME AND IDENTIFIED. THE CONTENTS, IF SELECTED, MATCH THE PATIENT JACKET AND DISPLAY THE SAME NAME AND IDENTIFIER. THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES. THIS ACTIVITY IS BEING COMPLETED AS PART OF A CORRECTIVE ACTION TAKEN PURSUANT TO AN FDA INSPECTION CONDUCTED AT THE FACILITY IN 2008.

    Description of Event or Problem · 1

    THE SITE RADIOLOGISTS REPORTED AN INCIDENT WHERE THE PRIOR PATIENT'S COMPARISON LIST WAS DISPLAYED WITHIN THE PATIENT JACKET. THE RADIOLOGISTS NOTICED THAT THE CURRENT PATIENT PACKET DISPLAYED DID NOT HAVE ANY PRIORS WHEN THE EXAM THEY HAD OPENED DID HAVE PRIORS. NO INJURY OR MISDIAGNOSIS WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK