BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTIS ONE

    MDR report key: 5597575 · Received April 22, 2016

    Report

    Report Number
    2240869-2016-40287
    Event Type
    Death
    Date Received
    April 22, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 22, 2016
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    OWB
    PMA / PMN Number
    K133580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS CONDUCTED A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. THE PARTS POTENTIALLY CAUSING THE EVENT WERE EXCHANGED AND PROVIDED FOR INVESTIGATION. ASSESSMENT OF THE COLLIMATOR AND LOG FILES IDENTIFIED SEVERAL COLLISIONS ON THE DAY OF THE EVENT . FOLLOWING THESE COLLISIONS, THE SYSTEM WAS ABLE TO BE FURTHER OPERATED AS THE COLLISION CONTROL WAS SELF-DEACTIVATED. AT THE TIME THE LAST COLLISION WAS RECORDED, THE SYSTEM MOVEMENTS WERE BLOCKED DUE TO DAMAGE TO THE INTERIOR OF THE COLLIMATOR AND THE COLLISION CONTROL COULD NO LONGER BE SELF-DEACTIVATED. THE COLLIMATOR WAS REPLACED AND THE SYSTEM WORKS AS SPECIFIED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED EVENTS IS CURRENTLY UNDER INVESTIGATION AND A ROOT CAUSE HAS NOT YET BEEN DETERMINED. DUE TO THE NATURE OF THIS EVENT, A REPORT IS BEING FILED AND A SUPPLEMENT REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION. THE TARGET OF THE ONGOING INVESTIGATION IS TO UNDERSTAND UNDER WHAT CIRCUMSTANCES THE COLLISION HAPPENED, WHY THE COLLISION DEVICE BECAME STUCK AND WHY "OVERRIDE" MODE WAS NOT USED. GENERALLY, AN ACTIVATED COLLISION DEVICE DOES NOT PREVENT THE SYSTEM FROM CONTROLLED MOVEMENT. FURTHER OPERATION IN THE SO CALLED "OVERRIDE" MODE IS STILL POSSIBLE. OPERATION IN "OVERRIDE" MODE MAY BECOME NECESSARY WHEN OPERATING CLOSE TO THE PATIENT. AS A PRECAUTION, THE MOVEMENT STOPS BEFORE GOING INTO "OVERRIDE" MODE TO ALLOW THE OPERATOR TO TAKE CONTROL OF FURTHER MOVEMENTS. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT DURING AN EMERGENCY PROCEDURE ON THE ARTIS ONE SYSTEM, CPR BECAME NECESSARY FOR THE FEMALE PATIENT. THE C-ARM WAS MOVED TO ACCESS THE PATIENT. WHEN MOVING THE C-ARM BACK TO POSITION, THE COLLISION PROTECTION DEVICE OF THE COLLIMATIOR WAS ACTIVATED AND COULD NOT BE RELEASED. THE OPERATOR WAS NOT AWARE OF THE OVERRIDE FUNCTION OF THE ARTIS ONE SYSTEM. AFTER 45 MINUTES THE PROTECTION DEVICE COULD BE RELEASED AND THE PROCEDURE COULD BE CONTINUED. THE FEMALE PATIENT PASSED AWAY DURING THE ONGOING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254157 ARTIS ONE INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM OWB SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10848600

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death