BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUVIZ DUAL

    MDR report key: 958523 · Received November 30, 2007

    Report

    Report Number
    3004761566-2007-00001
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 7, 2007
    Report Date
    November 8, 2007
    Manufacturer
    PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K071308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION ON THE MISLABELED IMAGE IS AS FOLLOWING: A MIS-LABELED IMAGE MAY, BUT NOT NECESSARILY LEAD TO WRONG DIAGNOSIS, CONSEQUENTLY THE LIKELIHOOD OF PATIENT BEING INJURED FURTHER DECLINES. POSITIONING INDICATION IS AVAILABLE ON THE DISPLAY, BY WHICH THE USER MAY BE ALERTED. CHANGE OF PATIENT POSITIONING IS RARELY NEEDED CLINICALLY. IN ADDITION TO "WORKLIST" APPLICATION, MULTIPLE METHODS ARE PROVIDED TO CHANGE THE POSITION SETTING. THE MIS-LABELED IMAGE IS HIGHLY RECOGNIZABLE BY KNOWLEDGEABLE AND EXPERIENCED CLINICAL PERSONNEL'S. THIS MIS-LABELED IMAGE MAY CONTRIBUTE TO MISDIAGNOSIS, WRONG MEDICATION AND EVEN INTERVENTIONAL TREATMENT AS A WORST CASE. ACTION PLAN IS: SEND FIELD SAFETY NOTICE TO END USERS/PLANNED FOR DECEMBER, 2007. IMPLEMENT MANDATORY FIELD CHANGE ORDER TO ALL AFFECTED SYSTEMS / PLANNED FOR JANUARY, 2008.

    Description of Event or Problem · 1

    DURING SYSTEM TRAINING COURSE TO THE END USER, THE SCANNER WAS SET TO A "WORKLIST" MODE. NO PATIENT WAS INVOLVED. THE SERVICE ENGINEER WAS DEMONSTRATING THE PROCEDURES: WHEN A PATIENT INFORMATION IS DOWNLOAD FROM WORKLIST AND SELECT A PROTOCOL TO ENTER SCAN PAGE, THE SCREEN SHOWS PATIENT ID, NAME AND SELECT POSITION. IF THE PATIENT IS RE-SELECTED FOR ANOTHER POSITION, THE SCREEN WILL SHOW THE PATIENT ID, NAME AND THE PREVIOUSLY SELECTED POSITION SETTING NOT THE NEW POSITION SETTING. IF THIS WERE TO OCCUR IN A REAL CLINICAL APPLICATION A MISLABELED IMAGE IS GENERATED WHICH COULD RESULT IN MISDIAGNOSIS. ADDITIONAL, THIS ERROR CAN BE DETECTED VIA CERTAIN ABBREVIATED TEXT ON THE SCREEN, BUT IT IS NOT OBVIOUS TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM JAK PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. NEUVIZ DUAL

    Patients

    Seq Age Sex Outcome Treatment
    1 YR