BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 5840362 · Received August 2, 2016

    Report

    Report Number
    2240869-2016-48067
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    July 9, 2016
    Report Date
    July 11, 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. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED A THOROUGH INVESTIGATION OF THE REPORTED EVENT. IT WAS DETERMINED THAT FLUID DID ENTER INTO THE INTERIOR OF THE PATIENT TABLE AT A GAP IN THE COVER TO THE TABLE BASE. TO PREVENT FLUID FROM ENTERING AT THIS SPOT, A CORRECTIVE ACTION WAS ALREADY INTRODUCED TO AFFECTED CUSTOMERS. WITH THIS CORRECTIVE ACTION, THIS GAP IS CLOSED AND IS PREVENTING FLUID FROM ENTERING. THIS ACTION WAS BEEN REPORTED TO THE FDA WITH THE FOLLOWING REPORT NUMBER: 2240869-07/02/15-0021-C.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE USING THE ARTIS ZEE FLOOR SYSTEM. THE CUSTOMER REPORTED THAT AFTER THE TABLE WAS FLOODED, THEY OBSERVED SMOKE AND INITIATED THE EMERGENCY STOP. TABLE LONGITUDINAL MOVEMENTS WERE THEN BLOCKED. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494277 ARTIS ZEE FLOOR INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM OWB SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1