BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 931387 · Received October 22, 2007

    Report

    Report Number
    9617251-2007-00002
    Event Type
    Malfunction
    Date Received
    October 22, 2007
    Date of Event
    September 21, 2007
    Report Date
    October 22, 2007
    Manufacturer
    SEDECAL S.A.
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIAGNOSTIC X-RAY SYSTEM EXPERIENCED UNCOMMANDED MOVEMENT OF THE TUBE-HEAD/BUCKY ASSEMBLY. THE ACTUAL CAUSE OF THIS MOVEMENT IS UNKNOWN AS OF THE DATE OF THIS REPORT. HOWEVER AND UPGRADE TO THE CONTROL LOGIC HAS BEEN MADE TO SYSTEMS MANUFACTURED DURING AND AFTER APRIL 2007 HAS BEEN IMPLEMENTED. THIS UPGRADE PREVENTS UNCOMMANDED SYSTEM MOVEMENT. THE SYSTEM THAT MALFUNCTIONS HAD NOT RECEIVED THIS UPGRADE. THE SYSTEM WAS REPLACED AND THE SYSTEM THAT MALFUNCTIONED HAS BEEN SENT TO SEDECAL USA FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE POSITIONER WAS IN THE UNDERTABLE POSITION, SID AT 100CM AND WITH A PATIENT ON A QUANTUM TABLE. WHILE THE X-RAY TECHNICIAN WAS POSITIONING THE PATIENT ON THE TABLE, THEY NOTICED THE U-ARM POSITIONER START TO MOVE IN THE DOWNWARD POSITION BY ITSELF. THE TECHNICIAN QUICKLY MOVE THE PATIENT OFF THE TABLE TO AVOID THE PATIENT BEING HIT BY THE MOVING TUBE/COLLIMATOR ASSEMBLY. THEY THEN NOTICED THE POSITIONER START TO TRAVEL IN THE UPWARD POSITION ON ITS OWN, WITH THE TABLE STILL OVER THE BUCKY. IT ACTUALLY LIFTED THE SEVERAL HUNDRED POUND TABLE COMPLETELY OFF THE FLOOR. THE POSITIONER CONTINUED TO MOVE UP PAST THE HEIGHT MOTOR LIMIT SWITCHES, CRUSHING THE MECHANICAL STOPS. THE CARRIAGE CABLE CAME COMPLETELY OFF THE PULLEY, WRAPPING AROUND THE HEIGHT POTENTIOMETER BRACKET. BESIDES THE MAJOR SAFETY ISSUE HERE, SEVERE DAMAGE OCCURRED TO THE POSITIONER. THE PATIENT WAS NOT INJURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR