BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIX MT

    MDR report key: 3496452 · Received November 19, 2013

    Report

    Report Number
    2240869-2013-09461
    Event Type
    Other
    Date Received
    November 19, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE SECTOR
    Product Code
    IZZ
    PMA / PMN Number
    K971452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS EQUIPPED WITH SAFETY FEATURES SUCH AS SPACER SLEEVES AND SECURING PINS TO PREVENT THE DESCRIBED CONDITION. HOWEVER, IN THE REPORTED CASE, THE SECURING PINS WERE FOUND TO BE OUTSIDE OF THE DESIGNATED SPACE. THE SECURING PINS ARE INSTALLED AT THE FACTORY AND THE ASSEMBLY IS DELIVERED COMPLETELY MOUNTED. IT IS ASSUMED THAT THE SECURING PINS WERE REMOVED DURING SYSTEM INSTALLATION AT THE FACILITY. THE ENGINEER REINSTALLED THE SECURING PINS AND REPOSITIONED THE TRANSVERSE BRIDGE ASSEMBLY TO SECURE THE SYSTEM. TO ENSURE THAT THE SYSTEM IS INSTALLED ACCORDING TO THE SPECIFICATIONS, A SPECIALIST WILL VISIT THE FACILITY TO CERTIFY THE UNIT. THIS REPORT WAS SUBMITTED ON (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SERVICING THE MULTIX UNIT, A SIEMENS ENGINEER NOTICED THE ROLLERS ON THE 3D TOP CEILING STAND MOVED MORE THAN 50% OUT OF THE RAIL. THE SECURING PINS FOR THE TRANSVERSE BRIDGE ASSEMBLY WERE STICKING OUT AND NOT LOCKING THE TRANSVERSE RAIL TO THE TRANSVERSE BRIDGE ASSEMBLY, THEREBY ALLOWING THE TRANSVERSE RAILS TO DRIFT. ALTHOUGH THERE HAVE BEEN NO REPORT OF ANY INJURIES IN THIS EVENT, THE WHOLE 3D ASSEMBLY COULD POTENTIALLY CRASH DOWN DURING AN EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600564 MULTIX MT TABLE, RADIOGRAPHIC, NON-TILTING, POWERED IZZ SIEMENS HEALTHCARE SECTOR 08395399 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other