BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDC/SEDECAL

    MDR report key: 797698 · Received September 27, 2006

    Report

    Report Number
    9617251-2006-00003
    Event Type
    Malfunction
    Date Received
    September 27, 2006
    Date of Event
    August 29, 2006
    Report Date
    September 27, 2006
    Manufacturer
    SEDECAL S.A.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN INVESTIGATION BY THE MFR, IT WAS DETERMINED THAT ALL THE MALFUNCTIONS WERE DUE TO INSTALLATION ERRORS. A SUBSEQUENT MALFUNCTION WAS DUE TO A WIRING ERROR MADE BY THE SVC ORGANIZATION. THE ROOT CAUSE OF THE INITIAL PROBLEM TURNED OUT TO BE A WIRING DIFFERENCE BETWEEN THE ORIGINAL TUBE STAND AND A REPLACEMENT TUBE STAND. THE CUSTOMER HAD ORDERED A REPLACEMENT SYSTEM WHICH INCLUDED THE LONGER CABLES DESIRED BY THE CUSTOMER. IN A SYSTEM, TUBE STANDS ARE MATCHED WITH THEIR CONTROL CABINETS AND ARE TESTED TOGETHER. WHEN THE REPLACEMENT SYSTEM ARRIVED, THE SVC ORGANIZATION CHANGED ONLY THE TUBE STAND, AND NOT THE CONTROL CABINET. THIS CREATED AN INCOMPATIBILITY WHICH CAUSED THE BRAKE FAILURE. THE TUBE STAND AND CONTROL CABINET SHOULD BOTH HAVE BEEN REPLACED TOGETHER. A THIRD MALFUNCTION OCCURRED WHICH WAS CAUSED BY A POORLY CRIMPED CONNECTION MADE BY THE SVC ORGANIZATION. CONCLUSION: ALL FAILURES WERE CAUSED BY FAULTY INSTALLATION(S), NOT BY DEFECTIVE EQUIPMENT.

    Description of Event or Problem · 1

    THIS WAS A MALFUNCTION OF A DIAGNOSTIC X-RAY SYSTEM WITH A MOTORIZED "C-ARM" STRUCTURE. A RADIOLOGY TECH WAS PREPARING THE DEVICE FOR AN X-RAY PROCEDURE AND WHILE LOWERING THE C-ARM PORTION OF THE STAND, THE UNIT LOST POWER CAUSING THE "C-ARM" TO MOVE DOWNWARDS IN AN UNCONTROLLED STATE AND IT STOPPED WHEN IT HIT A GURNEY TABLE. AFTER THIS HAPPENED, THE SYSTEM COULD NOT BE MOVED VERTICALLY UPWARDS SO THE LOCAL SVC CO WAS CALLED TO INVESTIGATE THE PROBLEM. THIS PROBLEM OCCURRED TWICE SUBSEQUENTLY, ONCE DURING SERVICING AND ONCE PRIOR TO A PROCEDURE. IN ALL CASES THERE WERE NO PTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDC/SEDECAL DIAGNOSTIC X-RAY SYSTEM MQB SEDECAL S.A. XPLORER 1600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *