BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOM ARTIS DBA

    MDR report key: 1121343 · Received August 11, 2008

    Report

    Report Number
    2240869-2008-00008
    Event Type
    Other
    Date Received
    August 11, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZI
    PMA / PMN Number
    K052202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS SERVICE WAS CONTACTED ON THE DAY OF THE INCIDENT. THE SYSTEM WAS CHECKED BY THE SIEMENS LOCAL SERVICE ENGINEER, (B) (4). THE IMAGE DRIVE WAS FAILING INTERMITTENTLY, WHICH MAY HAVE CAUSED THE SYSTEM TO RESTART. A HARD DRIVE IN THE IMAGE DISK ARRAY WAS REPLACED. THE SYSTEM WAS TESTED AND PERFORMS ACCORDING TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A CORONARY ANGIOGRAPHIC EXAM, THE IMAGING SYSTEM EXPERIENCED A TEMPORARY RESET. DURING THE RESET, THE SYSTEM WENT INTO BYPASS FLUORO. THE ACQUISITION WAS LOST FOR APPROXIMATELY ONE MINUTE. AT THE SAME TIME, THE PATIENT EXPERIENCED A CHANGE OF ARRYTHMIA. ACCORDING TO (B) (6), LEAD TECHNOLOGIST OF THE ANGIO DEPARTMENT AT THE HOSPITAL, NO CONTRAST WAS INJECTED WHILE THE SYSTEM WAS RESETTING. THE CORONARY SPASM WAS NOT DIRECTLY CAUSED BY THE SYSTEM RESET, RATHER BY THE CATHETER BEING IN THE ARTERY FOR EXTENDED PERIOD OF TIME. AFTER THE CATHETER WAS REMOVED, THE PATIENT WENT BACK TO NORMAL SINUS HEART RHYTHM, NO CPR WAS REQUIRED. THE PATIENT WAS STABILIZED AS A RESULT OF REMOVING THE CATHETER AND HE WAS ABLE TO FINISH THE EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS DBA SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS MEDICAL SOLUTIONS USA, INC. 07555357 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR