BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMUS HI

    MDR report key: 3488888 · Received November 5, 2013

    Report

    Report Number
    2910081-2013-09075
    Event Type
    Other
    Date Received
    November 5, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 8, 2013
    Product Code
    IYE
    PMA / PMN Number
    K123812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS' INVESTIGATION INTO THE REPORTED INCIDENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER NOTIFIED SIEMENS ON (B)(6) 2013 THAT PT TREATMENT AND PORTING FOR A THREE (3)-FIELD BREAST SETUP WITH TANGENTS CONSISTING OF FOUR (4) SEGMENTS (FIELD-IN-FIELD TECHNIQUE) HAD BEGUN AND TREATED THE A1 FIELD AND THE FIRST SEGMENT OF B1001 WHEN THE FLAT PANEL (FPP) EXTENDED AND B1001 WAS PORTED AS A DOUBLE EXPOSURE (2+2 MU). THE FPP THEN RETRACTED BY ITSELF AND THE CONTROL CONSOLE BEGAN BEEPING AS IF IT WERE TREATING. THE CUSTOMER HIT THE RAD OFF BUTTON AND INFORMED THE PHYSICIST OF THE OCCURRENCE. REPORTEDLY, WITHOUT CLOSING THE PT FROM TX DELIVERY, THE CUSTOMER DOWNLOADED B2 SEGMENTS AND MOVED THE GANTRY TO THE LATERAL TANGENT (FIELD B2001). THE TREATMENT COMPLETED WITHOUT ANY OTHER UNUSUAL BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569710 PRIMUS HI ACCELERATOR, LINEAR, MEDICAL IYE 04504200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SW V9.2.18| LANTIS VERSION 8.30R1| NO. (B)(4), SWV 2.3.31| PRIMEVIEW 3I 2.1 - MAT. NO. 08147675, SER.,