BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM MULTIX MT

    MDR report key: 4269192 · Received November 13, 2014

    Report

    Report Number
    2240869-2014-08382
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZZ
    PMA / PMN Number
    K971452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED SYSTEM WAS REPAIRED BY THE ENGINEER AND RETURNED TO SERVICE. A CUSTOMER SITE VISIT WAS PLANNED BY THE DEVELOPMENT EXPERT. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADD'L INFO HAS BEEN RECEIVED. CUSTOMER'S ADDRESS: (B)(6). THIS REPORT WAS FILED (B)(6) 2014.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE 3D TUBE WAS STIFF TO MOVE ON THE MULTIX MT SYSTEM AND REQUESTED SERVICE. A SIEMENS ENGINEER WAS DISPATCHED TO THE FACILITY. UPON INSPECTION THE ENGINEER NOTICED THAT HET TRANSVERSE ROLLER WAS HANGING OVER THE EDGE OF THE RAIL. THE SECURING PINS FOR THE TRANSVERSE BRIDGE ASSEMBLY CAME OUT AND WERE NOT LOCKING THE TRANSVERSE RAIL TO THE CARRIAGE UNSTABLE. ALTHOUGH THERE HAVE BEEN NO REPORT OF ANY INJURIES IN THIS EVENT, THE WHOLE 3D ASSEMBLY COULD POTENTIALLY CRASH DOWN DURING AN EXAMINATION. THE REPORTED EVENT OCCURRED IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732157 AXIOM MULTIX MT RADIOLOGIC TABLE IZZ SIEMENS MEDICAL SOLUTIONS USA, INC. 8395415 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other