BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACKET/PLUG ASSY

    MDR report key: 1279080 · Received January 7, 2009

    Report

    Report Number
    1518293-2008-00077
    Event Type
    Malfunction
    Date Received
    January 7, 2009
    Date of Event
    October 13, 2004
    Report Date
    November 3, 2004
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: L F FIELD SERVICE ENGINEER REPORTS: THE J-BOW CRACKED AROUND THE SCREW HOLES AT THE TOP OF THE J-BOW. THE HOLES WERE LARGER (WORN) THAN NORMAL WHICH INDICATES THAT THE J-BOW WAS USED AS A HANDLE TO MOVE THE INJECTOR AROUND. THE FSE STATED THAT THIS MAY BE PARTLY DUE TO THE POSITIONING OF THE CEILING BRACKET (NOT INSTALLED BY L-F) WHICH CAUSES THE USERS TO HAVE TO REACH MORE TO GET THE INJECTOR INTO POSITION. THIS CAUSES MORE LATERAL MOTION ON THE VERTICAL J-BOW ARM WHICH CAN RESULT IN UNEXPECTED STRESS AT THE J-BOW CONNECTION TO THE SUSPENSION ARM. SUSPENSION WAS REPLACED AND INJECTOR SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER. FROM MCMAHON MANUFACTURER: SUBJECT: J-BOW BREAK. WE ARE WRITING IN REFERENCE TO THE J-BOW FAILURE AT ONE OF YOUR CUSTOMER SITES. EXAMINATION OF THE SUBMITTED PHOTOGRAPHS SHOWS THE UPPER PORTION OF THE LF "J TUBE" AND THE PIVOT THAT IS SECURED TO THE TUBE WITH A COMBINATION OF SCREWS AND NUTS. THE TUBE IS BROKEN NEAR THE END AT A POINT ROUGHLY CORRESPONDING WITH THE END OF THE PIVOT. CLEARLY EVIDENT IN THE PHOTOGRAPHS IS THE ELONGATION OF THE HOLES IN THE TUBE USED TO SECURE THE TUBE TO THE PIVOT. SIGNS OF FRETTING AND MOVEMENT ARE ALSO OBVIOUS IN THE PHOTOGRAPHS. IT CAN BE ASSUMED THAT ROUGH HANDLING OVER A LONG PERIOD OF TIME CAUSED THE PARTS TO WEAR AND FLEX. SUCH CONTINUED USE WILL EVENTUALLY RESULT IN A CRACK IN THE TUBE. IT IS IMPORTANT TO NOTE THAT SUCH A FAILURE IS NOT SUDDEN. RATHER, IT IS A SLOW DETERIORATION THAT SHOULD HAVE BEEN REMEDIED THROUGH NORMAL PERIODIC MAINTENANCE AND CHANGES TO PROCEDURES. THIS DOES NOT APPEAR TO BE A DEFECT IN MATERIALS OR FABRICATION. THIS IS A NORMAL PART THAT HAS BEEN SUBJECTED TO HARSH USE WITHOUT COMPENSATING MAINTENANCE, REPAIR, OR REPLACEMENT PRIOR TO COMPLETE FAILURE. IT IS INTERESTING TO NOTE THAT WE HAVE SEEN A FEW OTHER PARTS WITH SIMILAR DAMAGE. THE PARTS WERE SUPPLIED TO US FOR EXAMINATION ALONG WITH BROKEN SUSPENSION ARMS. IN THOSE CASES IT WAS CLEAR THAT THE ARMS HAD BEEN SUBJECTED TO REPEATED ABRUPT STOPS AND OTHER ABUSIVE HANDLING. THE ELONGATED HOLES AND TUBE CRACKS IN THE "J TUBE" WERE CONSISTENT WITH THE DAMAGE TO THE SUSPENSION ARM. SINCE THAT TIME, THE SUSPENSION ARM HAS BEEN STRENGTHENED. NO AMOUNT OF PRODUCTION STRENGTHENING WILL PREVENT EQUIPMENT FROM FAILING AS A RESULT OF LONG-TERM ABUSE AND NEGLECT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A SUSPENSION ARM BROKE AND THE HEAD FELL. (J-BOW SUSPENSION ARM). THERE WAS NO REPORTED INJURY TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRACKET/PLUG ASSY CT POWER INJECTOR SYSTEM DXT LIEBEL - FLARSHEIM CO. CT9000ADV NA

    Patients

    Seq Age Sex Outcome Treatment
    1