BEUDAMED
    FDA Adverse Event Other Summary report: N

    M3 MICRO-MLC FOR SIEMENS

    MDR report key: 2222842 · Received August 8, 2011

    Report

    Report Number
    8043933-2011-00020
    Event Type
    Other
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BRAINLAB AG
    Product Code
    IYE
    PMA / PMN Number
    K020860
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL: THERE WAS NO PT IN THE TREATMENT ROOM AT THE TIME OF THE EVENT. THERE WAS NO USER INJURY. THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, AND ACCORDING BRAINLAB MEASURES TO REDUCE THE RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE REGARDING THIS ISSUE. THE BRAINLAB DEVICE WORKED ACCORDING TO SPECIFICATION, ON-SITE INVESTIGATION BY BRAINLAB HAS SHOWN THAT THE FIXATION MECHANISM OF THIS M3 WORKED AS INTENDED. SINCE THERE IS NO INDICATION OF A MALFUNCTION OR A QUALITY OR PERFORMANCE ISSUE WITH THE BRAINLAB DEVICE, AND ACCORDING BRAINLAB MEASURES TO REDUCE THE RISK TO BE AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE REGARDING THIS ISSUE. THE BRAINLAB DEVICE WORKED ACCORDING TO SPECIFICATION THERE ARE NO CORRECTIVE AND PREVENTIVE ACTIONS INTENDED BY BRAINLAB FOR THIS ISOLATED EVENT AT THIS POINT OF TIME.

    Description of Event or Problem · 1

    THE HOSPITAL INFORMED BRAINLAB THAT AFTER PLACING THE REMOVABLE BRAINLAB M3 MICRO-MULTILEAF-COLLIMATOR (MMLC) ON THE LINEAR ACCELERATOR, WHEN ROTATING THE GANTRY OF THE LINEAR ACCELERATOR FROM 6 O'CLOCK POSITION TO 12 O'CLOCK POSITION, THE M3 MMLC SLID OFF. ACCORDING TO THE HOSPITAL: THERE WAS NO PT IN THE TREATMENT ROOM AT THE TIME OF THE EVENT. THERE WAS NO USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M3 MICRO-MLC FOR SIEMENS MICRO-MULTI-LEAF COLLIMATOR IYE BRAINLAB AG 41600-5A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other