BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MLC - 120 (MULTILEAF COLLIMATOR)

    MDR report key: 2182109 · Received June 23, 2011

    Report

    Report Number
    2916710-2011-00071
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K990085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION WAS CONFIRMED, THE MULTILEAF COLLIMATOR (MLC) FIELD WAS MIRRORED (180 DEG. OUT). ROOT CAUSE: THE CUSTOMER'S IN-HOUSE SERVICE PERSONNEL MODIFIED THE WIRING HARNESS AND REMOVED THE LABELS FROM THE HARNESS; THEY THEN CONNECTED THE CABLE INCORRECTLY. THIS CUSTOMER SITE IS NOT ON VARIAN SERVICE CONTRACT. VARIAN SERVICE WAS CALLED-ON AT A LATER TIME. VARIAN SERVICE FAILED TO RECOGNIZE THAT THE CUSTOMER HAD ERRONEOUSLY CONNECTED J1/P2 AND J2/P1. THIS ISSUE HAS BEEN FOUND TO BE THE RESULT OF NEGLIGENCE/HUMAN ERROR ON THE PART OF THE CUSTOMER'S IN-HOUSE SERVICE PERSONNEL. VARIAN HAS DETERMINED THAT THE PROBABILITY OF SERIOUS INJURY AS A RESULT OF THIS ISSUE IS IMPROBABLE/EXTREMELY UNLIKELY TO OCCUR. THE PHYSICIAN BELIEVES THAT NO ADVERSE EFFECTS RESULTED FROM THIS EVENT. THE PHYSICIAN HAS OR WILL INFORM THE AFFECTED PTS OF TREATMENT THAT OCCURRED ON (B)(6) 2011. THE FACILITY IS ABIDING BY HIPPA REGULATIONS AND WILL DETERMINE WHAT PT INFO CAN BE RELEASED FOR VARIAN'S REVIEW. CORRECTIVE ACTION: THE WIRING HAS BEEN CORRECTED, HOWEVER THE BOARD CONNECTORS ARE ERRONEOUSLY LABELED IN DISAGREEMENT WITH THE CORRECT SILKSCREEN ON THE BOARD. A VARIAN SERVICE ENGINEER WILL BE DISPATCHED WITH FACTORY LABELS TO CORRECTLY RELABEL THE CABLES SO THIS ISSUE CANNOT HAPPEN AGAIN. THEY WILL DRESS THE CABLES WITH BLUE AND WHITE (AS NEEDED) TIE WRAPS SO THE J2/P1 ERROR CANNOT BE MADE. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    AFTER A MULTILEAF COLLIMATOR (MLC) REPAIR WAS COMPLETED BY THE SITE IN HOUSE ENGINEER AND TWO VARIAN FIELD SERVICE ENGINEERS, THE THERAPIST NOTICED THE MLC FIELD WAS MIRRORED (180 DEG OUT). SEVEN PTS WERE TREATED WITH THE MLC FIELD INVERTED BEFORE IT WAS DISCOVERED AND CORRECTED. THE ATTENDING PHYSICIAN BELIEVES THAT NO ADVERSE EFFECTS RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM MLC - 120 (MULTILEAF COLLIMATOR) ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H54

    Patients

    Seq Age Sex Outcome Treatment
    1