BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTISTAR D

    MDR report key: 1522743 · Received November 4, 2009

    Report

    Report Number
    2240869-2009-00035
    Event Type
    Death
    Date Received
    November 4, 2009
    Date of Event
    September 21, 2009
    Report Date
    November 2, 2009
    Manufacturer
    SIEMENS AG
    Product Code
    IZI
    PMA / PMN Number
    K930635
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS SERVICE RETURNED TO THE SITE FOR FURTHER INVESTIGATION AND TO GATHER ALL EVENT LOGS FROM THE EVENT. AFTER EXAMINATION OF THE EVENT LOGS, NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD BE IDENTIFIED. THE SYSTEM WAS IN BYPASS FLUORO WHEN THE EVENT OCCURRED. THE IMAGING SYSTEM WAS AVAILABLE FOR SAFE COMPLETION OF THE EXAM. WHEN THE OPERATOR REBOOTED THE SYSTEM, NO IMAGE WAS AVAILABLE FOR 3 MINUTES AND 1 SECOND. THE SYSTEM WAS SHOWN TO BE IN FULL OPERATION IN 7 MINUTES 36 SECONDS. NO UNINTENDED UNIT MOVEMENT WAS REGISTERED DURING THE REBOOT. OPERATOR-INITIATED MOVEMENT WAS REGISTERED WHEN THE SYSTEM WAS AGAIN OPERATIONAL. ADDITIONALLY, IN THE EVENT THE PATIENT NEEDS TO BE REMOVED FROM THE SYSTEM FOR ANY REASON, THE MULTISTAR D OPERATORS MANUAL DESCRIBES A PATIENT RESCUE FUNCTION THAT ALLOWS THE OPERATOR TO PULL THE TABLE OUT OF THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS BY GE HEALTHCARE THAT DURING AN EXAMINATION (BI-LATERAL ANGIO WITH STENT), THE SYSTEM ALLEGEDLY MALFUNCTIONED WHILE A PATIENT EXPERIENCED A CARDIO-PULMONARY EVENT TO WHICH THE PATIENT EXPIRED. SIEMENS WAS CALLED TO THE SITE FOR SERVICE FOLLOWING THE EVENT AS THE CUSTOMER REQUESTED SERVICE FOR "UNIT KEEPS SHUTTING DOWN DURING PROCEDURE." SIEMENS WAS NOT NOTIFIED THAT A PATIENT HAD EXPIRED IN THE ROOM DURING THE PROCEDURE. AT THE TIME OF SERVICE, THE SIEMENS SERVICE ENGINEER TROUBLESHOT THE SYSTEM FOR INTERMITTENT PROBLEMS WITH THE DVS (DIGITAL VIDEO SOURCE) AND FOR UNREQUESTED MOVEMENT OF THE STAND. PARTS WERE ORDERED AND REPLACED TWO DAYS LATER. AT THE TIME OF SERVICING, A CIRCUIT BOARD WAS RESEATED FOR THE DVS AND THE POWER SUPPLY WAS CHECKED WITH NO ADDITIONAL PROBLEMS FOUND. DURING A PHONE INTERVIEW WITH THE HOSPITAL PHYSICIST, SIEMENS WAS NOTIFIED THAT WHEN THE MALFUNCTION OCCURRED, THE SYSTEM WAS IN BYPASS FLUORO THEY WERE PUTTING THE LAST STENT INTO THE PATIENT. THE OPERATOR REBOOTED THE SYSTEM WHILE THE DOCTORS PERFORMED CPR. IT WAS REPORTED THAT THE SYSTEM ALLEGEDLY BEGAN MOVING ON ITS OWN. THE PATIENT WAS MOVED OFF THE TABLE INTO A STRETCHER WHERE CPR WAS CONTINUED. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISTAR D SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS AG 03772510

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death