BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS DRF

    MDR report key: 3964562 · Received May 23, 2014

    Report

    Report Number
    2240869-2014-04148
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OWB
    PMA / PMN Number
    K062623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE SIDE CONTROL WAS REPLACED AND RETURNED TO THE FACTORY FOR FURTHER INVESTIGATION. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD EXPERIENCED MULTIPLE ISSUES WITH THE TABLE. THE TABLE MOVEMENT IN DIFFERENT DIRECTIONS WAS ACTIVATED WITH A PUSH OF ONE BUTTON ON THE TABLE SIDE CONTROL CONSOLE (E.G. THE TABLE TRANSVERSE BUTTON ACTIVATED TABLE TRANSVERSE AND TABLE LIFT MOTION SIMULTANEOUSLY). THE CUSTOMER ALSO REPORTED THAT THE TABLE SPORADICALLY HAD NOT CARRIED OUT OF ANY MOVEMENTS. THE CUSTOMER CURRENTLY USES THE REMOTE CONTROL DURING THE EXAMINATION, BUT FINDS IT INCONVENIENT FOR MAKING PRECISION ADJUSTMENTS FOR LUMBAR AND THORACIC SPINE POSITIONING. THERE WERE NO INJURIES ASSOCIATED WITH THIS ISSUE. THE REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307309 AXIOM LUMINOS DRF IMAGE-INTENSIFIED FLUOROSCOPIC SYSTEM OWB SIEMENS MEDICAL SOLUTIONS USA, INC. 10094200 N.A.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other