BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPHANIX

    MDR report key: 3577256 · Received October 16, 2013

    Report

    Report Number
    3006972752-2013-00001
    Event Type
    Malfunction
    Date Received
    October 16, 2013
    Date of Event
    September 25, 2013
    Report Date
    October 14, 2014
    Manufacturer
    STEPHANIX
    Product Code
    OWB
    PMA / PMN Number
    K102529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS. THE FLUOROSCOPY TABLE SYSTEM IS MANUFACTURED BY STEPHANIX AND DISTRIBUTED IN THE USA BY VIRTUAL IMAGING INC WITH THE MODEL NUMBER D2-50RF. INITIAL STATEMENT BY THE HOSPITAL DOCTOR TO VIRTUAL IMAGING SERVICE ENGINEER STATED THAT EXTRA DOSE RECEIVED BY PT WAS WITHIN NORMAL EXAMINATION MARGINS. THIS SYSTEM INCORPORATES AN X-RAY GENERATOR MODEL SHF835 S/N (B)(4) MANUFACTURED BY SEDECAL THAT IS SUSPECTED TO BE ROOT CAUSE OF MALFUNCTION. THE D2-50RF SYSTEM HAS BEEN OUT OF OPERATION SINCE INCIDENT AND THE SEDECAL ENGINEERING TEAM WILL VISIT VIRTUAL IMAGING INC HQ IN (B)(4) WHERE A SIMILAR SYSTEM IS LOCATED IN ORDER TO TRY REPRODUCE THE PROBLEM AND INVESTIGATE IN DEPTH THE ROOT CAUSE, AND AFTER WORKING JOINTLY WITH VIRTUAL IMAGING PERSONNEL AND (B)(4) PERSONNEL WHERE THE INCIDENT OCCURRED IN ORDER TO EVALUATE DEVICE AND CONFIRM CURRENT HYPOTHESIS FOR THE MALFUNCTION AND TO INITIATE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS. VISIT IS SCHEDULED FOR CALENDER WEEK 42: F/U REPORT WILL BE SUBMITTED BASED ON FINDINGS.

    Description of Event or Problem · 1

    DURING A BE STUDY OF AN INFANT, THE DOCTOR RELEASED THE FLUOROSCOPY FOOT SWITCH AND WAS REPOSITIONING THE PT. AFTER SEVERAL SECONDS, THE DOCTOR NOTICED THE SYSTEM WAS CONTINUING TO RUN FLUOROSCOPY. THE DOCTOR EXERCISED THE FOOT SWITCH THINKING IT WAS STUCK WHICH DIDN'T RELEASE FLUOROSCOPY. AT THIS POINT, THE DOCTOR CALLED ASKED THE SERVICE ENGINEERS FOR ASSISTANCE AND THE SERVICE ENGINEERS CHECKED BOTH THE CONTROL ROOM AND EXAM ROOM FOOT PEDALS, ATTEMPTED TO RESET THE GENERATOR AND THEN SHUT DOWN THE EXAM TABLE USING THE E STOP BUTTON ON THE CONSOLE. THE SYSTEM CONTINUED TO RUN FLUOROSCOPY AND THE X-RAY GENERATOR WAS SHUT DOWN USING THE ON/OFF BUTTON FOR THE GENERATOR IN THE CONTROL ROOM. DOSE, FREQUENCY, ROUTE USED: 67 SECONDS OF FLUOROSCOPY AT 100KV, 20FPS. ESTIMATED DOSE EMITTED 17 MGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531598 STEPHANIX SYSTEM, X-RAY, FLUOROSCOPIC OWB STEPHANIX D2-50RF

    Patients

    Seq Age Sex Outcome Treatment
    1