BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 6072694 · Received November 2, 2016

    Report

    Report Number
    2240869-2016-54304
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    OWB
    PMA / PMN Number
    K123529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE SYSTEM HANDSWITCH WAS RETURNED IN A SEVERLY DAMAGED STATE. MOST OF THE HOUSING OF THE HAND SWITCH WAS MISSING. THE ROD CONNECTING THE ACQUISITION BUTTON WITH THE MICRO SWITCHES WAS EXPOSED, BENT AND STUCK IN THE "PRESSED" POSITION. SUCH DAMAGE CAN VERY LIKELY LEAD TO ACTIVATION OF RADIATION. THE LOG FILE ANALYSIS SHOW THAT THE UNINTENDED TRIGGERING (PRESSING OR RELEASING) OF THE HANDSWITCH ONLY HAPPENED CONCURRENTLY WITH LONGITUDINAL TABLE MOVEMENT. THIS LEADS TO THE CONCLUSION THAT THE COMPONENT WAS OBSTRUCTED ON OR NEAR THE PATIENT TABLE TOP WHICH MOST LIKELY LED TO THE DAMAGE AND XRAY RELEASE. THE HANDSWITCH WAS REPLACED AND THE SYSTEM WAS RETURNED TO CLINICAL USE. NO FURTHER NOTIFICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WITH THE ARTIS ZEE FLOOR SYSTEM. THE CUSTOMER REPORTED THE HAND SWITCH RELEASED AN UNINTENTIONAL SINGLE IMAGE WITHOUT FLUORO. SIEMENS HAS NO AWARENESS OF ANY INVOLVEMENT OF A PATIENT OR IMPACT TO THE STATE OF HEALTH OF ANYONE POTENTIALLY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725878 ARTIS ZEE FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1