BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE BIPLANE

    MDR report key: 4003098 · Received June 26, 2014

    Report

    Report Number
    2240869-2014-03742
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 27, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZI
    PMA / PMN Number
    K090745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS INITIATED A CORRECTIVE ACTION FOR ALL AFFECTED CUSTOMERS WITH UPDATE INSTRUCTIONS AX011/14/S AND AX007/14/S. THIS ACTION HAS BEEN REPORTED TO THE FDA UNDER REPORT # 2240869-06/11/14-0021-C. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS NOTIFIED THAT AN ARTIS ZEE BIPLANE SYSTEM DID NOT RELEASE X-RAY AT THE BEGINNING OF A PROCEDURE. THE INITIAL INVESTIGATION SHOWS A FAULTY COMMUNICATION OF THE MDM "MULTI DISPLAY MANAGER" AS THE POSSIBLE ROOT CAUSE OF THIS EVENT. THE PROBLEM WILL NOT OCCUR SYSTEMATICALLY, BUT SPORADIC. WHEN THE PROBLEM OCCURS, X-RAY IS BLOCKED UNTIL A REBOOT IS PERFORMED ACCORDING TO THE RESPECTIVE DESCRIPTION FROM THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373137 ARTIS ZEE BIPLANE SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS MEDICAL SOLUTIONS USA, INC. 10094141

    Patients

    Seq Age Sex Outcome Treatment
    1