BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS TF

    MDR report key: 2192592 · Received July 1, 2011

    Report

    Report Number
    2240869-2011-00023
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 30, 2011
    Manufacturer
    SIEMENS AG
    Product Code
    MQB
    PMA / PMN Number
    K051602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS IS AWARE OF THE POTENTIAL PROBLEM WITH THE TILT BUTTONS ON THE OPTIGRIP AND DISTRIBUTED THE SAFETY ADVISORY NOTICE IN JANUARY 2011. THE UPDATE WAS REPORTED TO FDA UNDER 2240869-01/13/11-0002-C "OPTIGRIP WARNING LETTER". THE SYSTEM WAS CHECKED BY THE LOCAL SIEMENS ENGINEER, (B)(4). THE ENGINEER REPORTED THAT THE UPDATE HAD ALREADY BEEN PERFORMED AT THIS SITE AND NEW BUTTONS HAD ALREADY BEEN INSTALLED ON THIS UNIT. THE ENGINEER REMOVED THE CONTROL HANDLE AND FOUND THAT THE WIRES THAT GO INTO THE OPTIGRIP HAD BECOME PINCHED AND SHORTED TO THE METAL FRAME. THE COMPLETE CONTROL HANDLE WAS REPLACED BY THE ENGINEER AND THE OPTIGRIP WAS SENT TO THE FACTORY FOR FURTHER INVESTIGATION. THE ENGINEER SHOWED THE DOCTOR INVOLVED IN THE REPORTED EVENT HOW TO USE THE EMERGENCY STOP PUSHBUTTONS TO STOP ALL DEVICE MOVEMENTS SHOULD IT BECOME NECESSARY. CUSTOMER'S ADDRESS: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO AN EXAM ON AN AXIOM LUMINOS TP, THE TABLE WAS DRIVEN VERTICALLY. THE TABLE BEGAN TILTING BY ITSELF AND THEN STOPPED WITHOUT USING THE OPTIGRIP CONTROL HANDLE. THE EVENT HAPPENED AT THE START OF THE CASE. THE PT WAS SITTING IN A CHAIR BETWEEN THE TABLE AND THE SPOT FILM DEVICE. THERE ARE NO INJURIES REPORTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM LUMINOS TF SOLID STATE X-RAY IMAGER MQB SIEMENS AG 10093902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other