BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOR IMPRESSION PLUS

    MDR report key: 1170306 · Received September 12, 2008

    Report

    Report Number
    2910081-2008-00033
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IYE
    PMA / PMN Number
    K993425
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    WE HAVE BECOME AWARE OF A POTENTIAL ISSUE WITH OUR OVERHEAD HANDCONTROL ASSEMBLY USED WITH OUR MEDICAL LINEAR ACCELERATOR. THE OVERHEAD HANDCONTROL ASSEMBLY IS MOUNTED TO THE FACILITY CEILING WITH MOUNTING BOLTS AND SECURED WITH SAFETY WIRES. THE OVERHEAD ASSEMBLY IS CAPABLE OF ROTATING 360 DEGREES AND ITS ARM ASSEMBLY EXTENDS APPROX 4 FEET AWAY HORIZONTALLY FROM THE CENTER AXIS AND A METALLIC CABLE IS CONNECTED AT THE END AND DROPS VERTICALLY APPROX 5 FEET. THE HAND CONTROL ASSEMBLY IS CONNECTED AT THE END OF THE METALLIC CABLE. DURING SCHEDULED ROUTINE PREVENTIVE MAINTENANCE SERVICE CALL, THE SERVICE ENGINEER DISCOVERED THAT THE MOUNTING SCREWS WERE LOOSE AND THE SAFETY WIRES WERE NOT INSTALLED. ITS IMPORTANT TO NOTE, NO PTS OR CLINICIANS WERE INVOLVED NOR ANY INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOR IMPRESSION PLUS ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1