BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA 1.5 MRI

    MDR report key: 1162221 · Received September 16, 2008

    Report

    Report Number
    2183553-2008-00038
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER WAS DISPATCHED TO THE SITE. THE FE REPLACED THE REAR CASTOR, AND SECURED IT WITH A NEW SCREW. ENGINEERING INVESTIGATION REVEALED THAT THE BUSHING WAS EXTENDED BELOW IN THE CASTING AN AMOUNT THAT IS GREATER THAN SPECIFIED IN THE PREVENTATIVE MAINTENANCE DIRECTIONS. THE DIRECTION CALLS OUT THAT THE BUSHINGS ARE NOT TO BE EXTENDED MORE THAN 6.35MM BEYOND THE BOTTOM OF THE CASTING. WHEN THE BUSHING IS EXTENDED BEYOND THIS LIMIT, THE TAPER INSIDE OF THE BUSHING WILL NO LONGER TIGHTEN SUFFICIENTLY AROUND THE CASTER TO HOLD IT IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT REAR CASTOR FELL OFF THE PATIENT TABLE DURING TRANSPORT OVER THE DOOR JAM OF THE MAGNET ROOM. A PATIENT WAS NOT ON THE TABLE AT THE TIME OF THIS EVENT. THE REAR CASTOR FELL AS A RESULT OF THE SCREW HOLDING THE CASTOR TO THE BRASS BUSHING HAS BROKEN. NO INJURY WAS REPORTED. THE PATIENT TABLE'S CASTER SCREW BREAKING COULD POTENTIALLY CAUSE A SIGNIFICANT INJURY TO EITHER THE PATIENT, OR THE TECHNOLOGIST ASSISTING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA 1.5 MRI LNH GE MEDICAL SYSTEMS, LLC 2357500-2

    Patients

    Seq Age Sex Outcome Treatment
    1