BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEAVTRON M2/PRIMUS MID-ENERGY

    MDR report key: 2655792 · Received July 5, 2012

    Report

    Report Number
    2910081-2012-05437
    Event Type
    Other
    Date Received
    July 5, 2012
    Date of Event
    June 6, 2012
    Report Date
    July 2, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS BECAME AWARE OF THE REPORTED EVENT ON (B)(4) 2012, AND THIS MDR IS BEING MAILED ON 07/03/2012. SIEMENS' INVESTIGATION INTO THE REPORTED ISSUE REVEALS THAT THE MINIMUM DISTANCE OF THE FLAT PANEL DURING GANTRY ROTATION HAS BEEN REDUCED INTENTIONALLY BY A SOFTWARE UPDATE. THE PREVIOUS SOFTWARE VERSIONS HAD LARGER DISTANCES. SAFETY INSTRUCTIONS CONTAINS WARNINGS THAT ADVISE THE USER TO "VERIFY ALL CLEARANCES BEFORE MOVING THE GANTRY WITH THE FLAT PANEL PORTAL IMAGER DEPLOYED" AND TO "VERIFY CLEARANCES BEFORE DEPLOYING OR RETRACTING THE FLAT PANEL PORTAL IMAGER." CUSTOMER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED ON (B)(4) 2012 THAT THE FLAT PANEL WILL NO LONGER MOVE TO 160 SID WHILE ROTATING BETWEEN FIELDS. REPORTEDLY, THE CUSTOMER STATED THAT THE FLAT PANEL USED TO AUTOMATICALLY MOVE BACK TO 160 SID AFTER EACH FIELD AND ROTATE. NOW THE FLAT PANEL HAS TO BE SET TO 144.9 SID OR LESS IN ORDER TO MOVE FOR ROTATION BETWEEN FIELDS. THE FLAT PANEL HAS COLLIDED WITH THE TREATMENT TABLE A FEW TIMES DURING PT TREATMENTS. HOWEVER, THERE ARE NO REPORTS OF MISTREATMENT OR INJURY TO A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEAVTRON M2/PRIMUS MID-ENERGY ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC., RADIATION ONCOLOGY 1940035 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 SW V4.2| 9.1 MR2