BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOURCE

    MDR report key: 1321745 · Received December 19, 2008

    Report

    Report Number
    8020711-2008-00010
    Event Type
    Malfunction
    Date Received
    December 19, 2008
    Date of Event
    November 24, 2008
    Report Date
    December 18, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    K071467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN INITIAL CORRECTIVE ACTION, A SERVICE TECHNICAL INFORMATION WAS ISSUED TO INFORM ALL FIELD SERVICE ENGINEERS ABOUT THE SITUATION. IF AN E9 ERROR MESSAGE IS DISPLAYED, THE USER HAS TO CONTACT VARIAN MEDICAL SYSTEMS IN ORDER TO CORRECT THE CAUSE. THIS IS ADVISED IN THE USER MANUAL. THIS REPORT IS BASED ON INFORMATION FROM THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS. BY SUBMITTING THIS REPORT, THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED HAS MALFUNCTIONS, IS DEFECTIVE OR HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE.

    Description of Event or Problem · 1

    ERROR DESCRIPTION: ON (B) (6) 2008 THE CUSTOMER REPORTED THAT A TREATMENT FRACTION WITH THE VARISOURCE IX AFTERLOADER WAS INTERRUPTED WITH AN E9 ERROR MESSAGE (AFTERLOADER HAS REPORTED DWELL COMPLETE WHILE ONE SECOND OR MORE IS STILL REMAINING). THE ERROR MESSAGE WAS DISPLAYED FOR POSITION 2 OF A 1 CHANNEL FRACTION (4 POSITIONS). THE PLANNED DWELL TIME WAS 624.81S AND THE DWELL ITEM IN POSITON 2 WAS 156.80S. THE ABOVE ERROR MESSAGE INDICATES THAT THE AFTERLOADER DID NOT COMPLETE THE PLANNED TREATMENT TIME AND IN THIS CASE THE MISSING TREATMENT TIME WAS 65.5S IN POSITION 2. THE TREATMENT DELIVERY RECORD STATED THAT THE DWELL TIME IN POSITION 2 WAS COMPLETED WHILE THE CONSOLE SOFTWARE INDICATED THAT THERE WAS 65.5S REMAINING TO COMPLETE THE PLANNED DWELL TIME IN POSITION 2. IN THE CONTINUATION OF THIS FRACTION, THE 65.5S IN POSITION 2 WERE NOT TREATED. IN SUMMARY ALL 4 POSITIONS WERE TREATED, BUT THE TOTAL DELIVERED TREATMENT TIME WAS 559.31S INSTEAD OF 624.81S FOR THIS FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISOURCE BRACHYTHERAPY SYST, REMOTE AFTERLOAD JAQ VARIAN MEDICAL SYSTEMS IX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other