BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUENCER

    MDR report key: 796460 · Received December 13, 2006

    Report

    Report Number
    2950347-2006-00003
    Event Type
    Injury
    Date Received
    December 13, 2006
    Date of Event
    November 13, 2006
    Report Date
    December 13, 2006
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    KPQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IMPAC HAS DETERMINED THAT A PARTIAL UPGRADE (INCORRECT SET OF DLLS AND MACHINE CONFIGURATION CHANGES) HAD A DETRIMENTAL IMPACT AT A CUSTOMER SITE. FOLLOWING AN ELEKTA CONSOLE UPGRADE, ONE OF IMPAC'S SUPPORT PERSONNEL INCORRECTLY CONFIGURED THE SITE TO USE ELEKTA RTD6 WITH SEQUENCER/MULTI-ACCESS 8.30I0. THIS VERSION OF SEQUENCER/MULTI-ACCESS DOES NOT SUPPORT RTD6. INCORRECT VALUES FOR WEDGES WERE PASSED TO THE TREATMENT MACHINE AND SEQUENCER DID NOT CATCH THE MISMATCH AND ALLOWED BEAM TO BE DELIVERED. IMPAC HAS TAKEN ADEQUATE PRECAUTIONARY STEPS TO PREVENT ANY POTENTIAL FOR FURTHER PATIENT MISTREATMENT BY RECONFIGURING SEQUENCER/MULTI-ACCESS 8.30 I0 FOR RTD5 AT THE SITE. FOLLOWING THIS, A FULL UPGRADE WAS PERFORMED TO SEQUENCER 8.30N5, CONFIGURATION TO RTD6 WAS DONE, AND THE MACHINE WAS TESTED TO INSURE PROPER FUNCTIONALITY. IMPAC HAS DISCUSSED THE ROOT CAUSE OF THE PROBLEM WITH THE AFFECTED SITE, PROVIDED A SOFTWARE UPGRADE TO CORRECT THE PROBLEM, AND REVIEWED ALL RECORDS WITH THE SITE TO ENSURE THAT ALL TREATMENT RECORDS ARE UPDATED TO REFLECT TREATMENT ACCURACY FOR THE 12 PATIENT TREATMENTS THAT OCCURRED BEFORE THE PROBLEM WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENCER RECORD AND VERIFY SYSTEM KPQ IMPAC MEDICAL SYSTEMS, INC. 18 .0 .1 .2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other RADIATION THERAPY TREATMENT SYSTEM (MANY DEVICES)