BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 5614426 · Received April 28, 2016

    Report

    Report Number
    2240869-2016-01899
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION AND A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED AT THE CLOSE 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 DURING A PROCEDURE ON THE ARTIS ZEE FLOOR SYSTEM, THE PATIENT URINATED ON THE TABLE. THE OPERATOR HEARD A LOUD POP AND SAW SMOKE. THE SYSTEM WAS TURNED OF VIA THE EMERGENCY OFF SWITCH AND THE PROCEDURE COULD NOT BE CONTINUED. THERE WAS NO IMPACT TO THE STATE OF HEATH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272866 ARTIS ZEE FLOOR SYSTEM, XRAY, ANGIOGRAPHIC IZI SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1