BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUVIZ DUAL

    MDR report key: 1663473 · Received February 12, 2010

    Report

    Report Number
    3004761566-2010-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 24, 2010
    Report Date
    January 26, 2010
    Manufacturer
    PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.
    Product Code
    JAK
    PMA / PMN Number
    K071308
    Removal / Correction Number
    3004761566-01/10/2010-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION : THE FOUR SCREWS THAT SECURE THE PT TABLE TOP TO THE CARRIER DID NOT HAVE THE PROPER WASHERS IN THE PLACE WHICH CAUSED THE TABLE TOP TO DETACH. THE PT THAT WAS ON THE TABLE AT THE TIME OF EVENT DID NOT SUFFER ANY INJURY. INVESTIGATION CONCLUDED THE PROBLEM MAY AFFECT NEUVIX DUAL SCANNERS, SOME OF WHICH MAY BE MISSING FIXTURE METAL WASHERS AS REQUIRED. ACTION PLAN IS AS FOLLOWING: A FIELD SAFETY NOTICE WILL BE SENT TO ALL END USERS BY (B)(6) 2010. THE LETTER WILL BE SENT BY CERTIFIED MAIL. MANDATORY FIELD CHANGE ORDER AND FCO KITS WILL BE RELEASED TO ALL AFFECTED SYSTEMS. THE MANDATORY FIELD CHANGE ORDER IS EXPECTED BY (B)(6) 2010. ALL AFFECTED SYSTEMS WILL BE UPDATED WITH AFOREMENTIONED KITS IN 6 MONTHS AFTER THE RELEASE.

    Description of Event or Problem · 1

    AN URGENT FIELD PROBLEM REPORT WITH RESPECT TO THE CT PT TABLE TOP DETACHMENT WAS RECEIVED ON (B)(6) 2010. THE PT THAT WAS ON THE TABLE AT THE TIME OF EVENT DID NOT SUFFER ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUVIZ DUAL JAK, MULTI-SLICE CT SCANNER SYSTEM JAK PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. 989605651331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK