BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 1076163 · Received July 10, 2008

    Report

    Report Number
    9617251-2008-00001
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    SEDECAL S.A.
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIAGNOSTIC X-RAY SYSTEM EXPERIENCED UNCOMMANDED MOVEMENT OF THE TUBE-HEAD/BUCKY ASSEMBLY (AKA "C-ARM"). AN UPGRADE TO THE CONTROL LOGIC HAS BEEN MADE TO SYSTEMS MANUFACTURED DURING AND AFTER APRIL 2007. THIS UPGRADE PREVENTS UNCOMMANDED SYSTEM MOVEMENT. THE SYSTEM THAT MALFUNCTIONED HAD NOT RECEIVED THIS UPGRADE. THE SYSTEM WAS REPAIRED AND THE UPGRADE APPLIED. SEDECAL HAD PREPARED A LIST OF ALL SYSTEMS REQUIRING THE UPGRADE AND IS IN THE PROCESS OF APPLYING THE UPGRADE TO ALL AFFECTED SYSTEMS IN THE FIELD.

    Description of Event or Problem · 1

    THE DEVICE IS A STATIONARY DIAGNOSTIC X-RAY SYSTEM WITH A MOTORIZED "C-ARM" TUBEHEAD/BUCKY ASSEMBLY. THE TECHNOLOGIST WAS PREPARING TO DO FOOT STUDY. THE TUBE WAS ROTATED TO POINT DOWN TO THE FLOOR. THE FIRST EXPOSURE WAS TAKEN. PREPARING TO MAKE A STANDING FOOT EXPOSURE, THE C-ARM WAS THEN ANGLED TO LESS THAN 90 DEGREES WITH THE TUBE POINTING TO THE FLOOR. THE TECHNOLOGIST ADJUSTED THE TUBE (SID) REDUCING THE DISTANCE BETWEEN THE TUBE AND THE BUCKY TO IMPROVE THE ALIGNMENT TO THE DIGITAL SENSOR. WHILE THE TUBE WAS MOVING, AN ERROR WAS DISPLAYED ON THE LED INDICATOR. THE TECH WAS NOT SURE OF THE ERROR CODE; MAYBE -31. AT THIS POINT, THE SYSTEM FROZE. THE TECH WAS UNABLE TO MAKE THE SYSTEM RESPOND. SHE REBOOTED THE SYSTEM. DURING THE BOOTING PROCESS THE LED DISPLAY FLASHED AN ERROR CODE WITH A LINE THROUGH IT. THE LCD DISPLAY HAD LINES THROUGH THE DISPLAY AND WAS ALSO FLASHING. TECH THEN TRIED TO MOVE THE CARRIAGE DOWN BY DEPRESSING THE DOWN BUTTON AT THE CONTROL PANEL BUT IT DID NOT RESPOND. SHE RELEASED THE DOWN BUTTON AND SUDDENLY THE CARRIAGE BEGAN TO MOVE DOWN SLOWLY. THE CARRIAGE CONTINUED TO MOVE DOWN TO THE FLOOR. THE STEEL CABLE BEGAN TO UNWIND AFTER THE CARRIAGE CAME INTO CONTACT WITH THE FLOOR. AFTER HEARING A NOISE FROM THE REAR OF THE UNIT THE TECH HIT THE EMERGENCY STOP BUTTON AND THE MOTION STOPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1