BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANTIS COMMANDER 10 USER

    MDR report key: 737005 · Received June 27, 2006

    Report

    Report Number
    2910081-2006-00004
    Event Type
    Other
    Date Received
    June 27, 2006
    Date of Event
    May 22, 2006
    Report Date
    June 20, 2006
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    LNX
    PMA / PMN Number
    k981313
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPAC MEDICAL SYSTEM RECENTLY ALERTED SIEMENS MEDICAL SOLUTIONS REGARDING A PRODUCT PROBLEM IN RELATED TO THEIR MULTI-ACCESS APPLICATION THAT COULD AFFECT THE VARIAN MLC INTERFACE APPLICATION IF THE MACHINE CONFIGURATION IS ALTERED. IMPAC'S MULTI-ACCESS IS EQUIVALENT TO SIEMENS MEDICAL SOLUTION'S BRAND NAME LANTIS. IMPAC MEDICAL SYSTEM, INC. IS RESPONSIBLE FOR SOFTWARE DEVELOPEMENT. IMPAC'S VARIAN MLC INTERFACE APPLICATION IS EQUIVALENT TO SMS' BRAND NAME. ACTIONS: A SAFETY ADVISORY LETTER WILL BE SENT TO ALL CUSTOMER SITES THAT HAVE THE PRODUCTS. A SAFETY ADVISORY LETTER, AS SEEN IN ATTACHMENT #3, WILL BE SENT TO ALL CUSTOMERS THAT HAVE THESE FEATURES. STOP SHIPMENT WAS ISSUED BY SMS ON VARIAN MILLENIUM AND NO MILLENIUM PRODUCTS. ACTION FOR STOP SHIPMENT WILL BE LIFTED ONCE THE ADVISORY LETTER IS RELEASED FOLLOW-UP: THE INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    PATIENT INVOLVEMENT: NO EVENT OCCURRED ON PRODUCT DISTRIBUTED BY SIEMENS MEDICAL SOLUTIONS. NO PATIENT INJURY REPORTED. THERE IS POTENTIAL HARM TO PATIENT CONFIGURATION FILE. NO EVENT REPORTED TO SIEMENS MEDICAL SOLUTIONS OCS. ELECTRONIC MAIL RECEIVED FROM MANUFACTURER IMPAC MEDICAL SYSTEM REGARDING A PRODUCT PROBLEM. COMPLAINT WAS RECEIVED BY SIEMENS MEDICAL SOLUTIONS IN 2006. COMPLAINT AS STATED: "VARIAN MLC INTERFACE APPLICATION, SPECIFICALLY VERSION H. MULTI-ACCESS IS ABLE TO INTERFACE WITH ALL VERSIONS THROUGH VERSION G; HOWEVER, MULTI-ACCESS HAS NOT YET BEEN RELEASED FOR USE WITH VERSION H. ALTHOUGH THE CUSTOMERS ARE NOT SUPPOSED TO CHANGE THE MACHINE CONFIGURATION FILE, AND REASONABLE READ-ONLY PROTECTION OF THE FILE IS IN PLACE, CUSTOMERS MAY STILL EDIT THE FILE TO IDENTIFY VERSION H. IF THIS OCCURS, AND THE MLC3PI INTERFACE IS BEING USED (THE DATA TAP WILL PREVENT SUCH MISUSE BECAUSE OF ITS BUILT-IN FAIL-SAFE), ANY IMRT PLANNED TREATMENT WILL BE DELIVERED AS A STATIC FIELD BASED UPON THE FIRST SHAPE OF THE IMRT PRESCRIPTION. EVERY SUBSEQUENT IMRT TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANTIS COMMANDER 10 USER VARIAN MILLENIUM/VARIAN NON MILLENIUM LNX SIEMENS MEDICAL SOLUTIONS USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other LANTIS COMMANDER 10 USER SW 6.1H4