BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUCKY ASSY, GE 8000 SERIES 115V

    MDR report key: 1307505 · Received February 10, 2009

    Report

    Report Number
    1518293-2008-00127
    Event Type
    Malfunction
    Date Received
    February 10, 2009
    Date of Event
    August 3, 2006
    Report Date
    September 28, 2006
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL - FLARSHEIM MANUFACTURER REPORT: THE BUCKY IS DESIGNED WITH A STOP FORMED INTO THE BUCKY. HOWEVER, THE ADDED BOLT AND NUT INSTALLED IN FRONT OF THE FORMED TRAY STOP TAB PROVIDES ADDITIONAL PROTECTION TO STOP A CASSETTE TRAY FROM COMING COMPLETELY OUT OF THE BUCKY CABINET. THE BOLT AND NUT WAS MISSING BECAUSE THE OPERATOR FAILED TO INSTALL IT ON THE BUCKY. VIEW "D" ON DRAWING CALLS FOR THE SCREW AND NUT AND PROCESS TEXT PRGEB 20 CALLS FOR IT IN SECTION II STEP 12B. I RETRAINED ON ASSEMBLY PROCESSES PRGEB 20, PRGEB 40, AND PRGEB 50 AND THIS TRAINING WILL BE FORMALLY ENTERED INTO THEIR TRAINING RECORDS. DURING THE WEEK ENDING 2006 (5) MORE BUCKY'S WERE BUILT. THESE BUCKY'S WERE AUDITED BY QC INSPECTOR AND ALL WERE ASSEMBLED CORRECTLY INCLUDING THE TRAY STOP SCREW. A REVIEW OF CTS SHOWS NO SIMILAR COMPLAINTS, AND DISCUSSIONS WITH OUR TECH SERVICE GROUP INDICATED THAT THEY HAVE NOT RECEIVED ANY SIMILAR FIELD ISSUES.

    Description of Event or Problem · 1

    LF QA CALLED TO REPORT; "GE REPORTS THAT THE LATE 2005 BUCKY WAS MISSING A TRAY STOP SCREW AND NUT. CUSTOMER LATER REPORTED THE REPLACEMENT BUCKY, MFG. JUNE 2006 WAS ALSO MISSING THE TRAY STOP SCREW AND NUT. THE SCREW AND NUT ARE USED TO REINFORCE THE EXISTING FORMED STOP IN THE BUCKY CABINET. ADDENDUM 10/10/08: GE PSR STATES, CUSTOMER REPORTED THAT WHEN THE TECHNOLOGIST PULLED THE TABLE CASSETTE HOLDER, IT DID NOT MECHANICALLY STOP AND THEREFORE HIT THE TECHNOLOGIST LEG. UPON INSPECTION, THE MECHANICAL STOPPER FOR THE CASSETTE HOLDER WAS BENT WHICH CAUSED THE CASSETTE TO BE PULLED ALL THE WAY. TECHNOLOGIST SUSTAINED BRUISES ON THE POSTERIOR PART OF THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUCKY ASSY, GE 8000 SERIES 115V BUCKY TRAY KPR LIEBEL - FLARSHEIM CO. 8000 SERIES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other