BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM VERTIX MD TRAUMA

    MDR report key: 3843592 · Received February 12, 2014

    Report

    Report Number
    2240869-2014-00637
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 2014
    Manufacturer
    SIEMENS HEALTHCARE
    Product Code
    KPR
    PMA / PMN Number
    K802200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE OTHER VERTIX MD TRAUMA SYSTEMS HAVE BEEN CHECKED BY SIEMENS LOCAL SERVICE AND NO PROBLEMS HAVE BEEN DETECTED. TO ELIMINATE ANY POTENTIAL HAZARD SIEMENS WILL BE INITIATING AN UPDATE FOR THE CONCERNED VERTIX MD TRAUMA SYSTEMS TO CHECK THE STEEL CABLES AND IF NECESSARY REPLACE THEM. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFO HAS BEEN RECEIVED. THIS REPORT WAS SUBMITTED FEBRUARY 11, 2014. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXAM ON THE AXIOM VERTIX MD TRAUMA SYSTEM TWO STEEL CABLE ON THE CEILING SUPPORT GOT RAPTURED CAUSING THE U-BRACKET (TUBE AND DETECTOR) TO FALL DOWN. THE PT LYING BELOW THE U-BRACKET ON THE BED WAS NOT INJURED AS THE SUPPORT ARM WITH THE DETECTOR AND THE TUBE LANDED BESIDE THE PT. ACCORDING TO INFO PROVIDED DURING THE ON-SITE VISIT THE OPERATOR'S HAND GOT BRUISED DUE TO THE INCIDENT. THE REPORTED EVENT OCCURRED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93609 AXIOM VERTIX MD TRAUMA SYSTEM, X-RAY, STATIONARY KPR SIEMENS HEALTHCARE 8908290 NA

    Patients

    Seq Age Sex Outcome Treatment
    1