BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDC/SEDECAL

    MDR report key: 797724 · Received March 24, 2006

    Report

    Report Number
    9617251-2006-00002
    Event Type
    Malfunction
    Date Received
    March 24, 2006
    Date of Event
    March 15, 2006
    Report Date
    March 24, 2006
    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

    EVAL SUMMARY: THE PRELIMINARY INVESTIGATION REVEALED EXCESS "PLAY" IN 1 OF THE SUPPORT BEARINGS. THE UNIT HAS BEEN SHIPPED BACK TO THE MFR IN FOR FURTHER EVAL. AN UPDATE WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A TEMPORARY RADIOLOGY TECHNICIAN WAS IN THE X-RAY ROOM AT THE TIME OF THE PROBLEM. THE X-RAY UNIT WAS IN POSITION FOR A 72" CHEST X-RAY, AND HE WAS STARTING TO BRING IT INTO POSITION TO DO A STANDING KNEE X-RAY. THE MOTION WAS ROUGH, AND HE ENCOUNTERED AN E06 ERROR CODE. ACCORDING TO THE TECH, THERE WAS NO OBSTRUCTION TO THE MOVEMENT OF THE C-ARM. HE CALLED ON A MORE EXPERIENCED TECH FOR ASSISTANCE. THEY RECYCLED POWER AND THE ERROR CODE CLEARED. AS THEY DROVE THE C-ARM DOWN, THE UNIT CRASHED FROM ABOUT 30 INCHES HEIGHT TO THE FLOOR. THE TECHNICIAN STATED THAT IT SEEMED TO HIM THAT THE UNIT WAS IN "FREE FALL" RATHER THAN A RAPID DRIVE DOWNWARD.

    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 *