BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUVIZ DUAL

    MDR report key: 1054898 · Received May 30, 2008

    Report

    Report Number
    3004761566-2008-00001
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 22, 2008
    Manufacturer
    PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K071308
    Removal / Correction Number
    3004761566-05/22/08-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND OCCURRENCE OF THE SAME ISSUE REPORTED TO PNMS JUNE 2007, TO WHICH AN ACTION FOR PERFORMANCE FIELD ACTIVITY WAS PROVIDED, BUT NOT YET FULLY IMPLEMENTED. THE FIRST INCIDENT WAS NOT REPORTED BASED ON THE LACK OF INFO ON HOW PARTS COULD MOVE WHEN A FAILURE OCCURS. A SECOND HAZARD ANALYSIS IN RESPONSE TO THIS REPORT IDENTIFIED A POTENTIAL THAT THE PARTS COULD ESCAPE THE GANTRY AND CAUSE AN INJURY AND THE FIELD ACTION WAS RECLASSIFIED AS MANDATORY RETROFIT ACTION. THE RISKS ASSOCIATED WITH THE ISSUE ARE: THE DEVICE MAY BE DAMAGED AND DE-FUNCTIONALIZED; THOUGH EXTREMELY UNLIKELY, THE INTERNAL COMPONENTS COULD BE EXPELLED FROM THE SYSTEM GANTRY AND INJURE THE PT, OPERATOR, BYSTANDER, OR SERVICE PEOPLE. THE MOST REASONABLE PROBABILITY OF INJURY OCCURING IS DETERMINED TO BE REMOTE: R-HOST IS INSIDE THE GANTRY AND CONNECTED WITH OTHER CABLES, SO IT IS VERY UNLIKELY TO EXPEL FROM THE GANTRY AND TO RESULT IN ANY INJURY TO THE PT OR THE USER. GANTRY COVERS ARE DESIGNED TO SECURE ITS MECHANICAL STRENGTH, WHICH MAY PROTECT HUMAN FROM INJURY IN CASE OF EXPELLED PARTS. A VERY STRONG NOISE CAN BE HEARD IN THIS SITUATION SO THAT THE OPERATOR CAN PRESS THE EMERGENCY BUTTON TO STOP THE DEVICE. IMMEDIATE PLAN IS TO: SEND FIELD SAFETY NOTICE TO END USERS/PLANNED FOR MAY, 2008. IMPLEMENT MANDATORY FIELD CHANGE ORDER TO ALL AFFECTED SYSTEMS/PLANNED FOR JUNE 2008 AND EXPECTED TO BE COMPLETED WITHIN 6 MOS.

    Description of Event or Problem · 1

    INCIDENT WAS REPORTED FROM A FOREIGN COUNTRY, THAT THE R-HOST BOX AND COMPONENTS INSIDE WERE DETACHED OF ITS MOUNTING DURING THE GANTRY ROTOR ROTATION. SEVERAL COMPONENTS WERE DAMAGED INSIDE THE SYSTEM GANTRY. NO PARTS ESCAPED THE GANTRY. NO INJURY TO PTS OR USERS OCCURRED. INVESTIGATION CONCLUDED THAT THE PROBLEM MAY AFFECT NEUVIZ DUAL CT PRODUCTS DUE TO POOR QUALITY OF R-HOST WELDING SPOTS.

    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. 989605651321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA