BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 846116 · Received May 9, 2007

    Report

    Report Number
    9617251-2007-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 8, 2007
    Manufacturer
    SEDECAL S.A.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPRING COUNTER WEIGHT CABLE HAD BROKEN ON THE TOP SECTION OF THE COLUMN COUNTER WEIGHT SPRING. THE LOUD NOISE WAS THE TENSION IN THE SPRING BEING RELEASED AS THE CABLE BROKE. WE TOOK THE UNIT APART AND DISASSEMBLED THE URS ON THE GROUND TO CHECK FOR ANY DAMAGE CAUSED BY THIS SPRING HITTING THE BOTTOM OF THE STAND AND ALSO TO INSPECT THE SAFETY MECHANISM. I TOOK EXTRA CARE TO LOOK AT THE SAFETY LATCH THAT IS DESIGNED TO ACTIVATE IF THE MAIN SPRING COUNTERWEIGHT CABLE WERE EVER TO BREAK. I NOTICED THAT ON THE METAL BEARING RAIL WHICH IS ALSO THE SAME RAIL THAT THE SAFETY LATCH WILL ACTIVATE ON AND STOP MOVEMENT, THERE WERE SEVERAL SPOTS ON THIS RAIL WHERE THE SAFETY TRIED TO ENGAGE AS THE UNIT FELL DOWNWARDS. IT FINALLY DID ENGAGE NEAR THE END OF TRAVEL. I SENT ALL OF THE INFO ALONG WITH IMAGES THAT I TOOK TO ENGINEERING AND SERVICE SUPPORT IN ANOTHER COUNTRY. AFTER AN INVESTIGATION OF SEVERAL FACTORS THAT COULD HAVE CAUSED THIS ACTION, THE FOLLOWING CONCLUSIONS WERE REACHED. THIS UNIT WAS RETROFITTED WITH A TRIXELL DIGITAL PANEL WHICH WEIGHS ABOUT 50 POUNDS MORE THAN A REGULAR BUCKY ASSEMBLY. THIS UNIT WAS NOT INITIALLY DESIGNED FOR THIS ADD'L WEIGHT OF THE DIGITAL DETECTOR. THE ADD'L WEIGHT WOULD REQUIRE AN IMPROVED SAFETY SPRING ADDED TO THE SAFETY DEVICE TO PROPERLY ENGAGE IF THIS WERE TO HAPPEN IN THE EVENT OF A CABLE BREAK. THE SERVICE MANUAL CLEARLY INDICATES IN THE PREVENTIVE MAINTENANCE SECTION THAT THIS MAIN COUNTERPOISE CABLE MUST BE INSPECTED EVERY 12 MONTHS FROM INSTALLATION. THIS INSPECTION HAD NOT BEEN DONE. A STRONGER CABLE AND LARGER PULLEY WOULD BE INSTALLED TO HELP CARRY THE ADD'L WEIGHT OF THE DIGITAL DETECTOR.

    Description of Event or Problem · 1

    TECHNICIAN WAS PREPARING SYSTEM FOR NEXT PT. THE POSITION OF THE URS TUBE AND RECEPTOR ARM WAS IN A CHEST STAND EXPOSURE POSITION AND WAS APPROXIMATELY 5 FEET FROM THE FLOOR AS MEASURED FROM THE COLLIMATOR. WHILE PRESSING THE VERTICAL DOWN BUTTON ON THE URS CONTROL PANEL TO DRIVE THE TUBE AND RECEPTOR LOWER, THE URS BEGAN TO MOVE AND THEN THE ARM FELL DOWNWARDS UNTIL IT APPEARED TO HIT THE FLOOR. DURING THE FALL OF THE UNIT, THERE WAS A VERY LOUD NOISE THAT CAME FROM THE UNIT. THE OPERATOR COULD SEE THAT THE MAIN CABLE HAD BEEN BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDECAL DIAGNOSTIC X-RAY SYSTEM MQB SEDECAL S.A. URS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR