BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISTE MV SYSTEM

    MDR report key: 3021891 · Received March 26, 2013

    Report

    Report Number
    2910081-2013-01928
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYE
    PMA / PMN Number
    K090783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMEN'S INVESTIGATION INTO THE REPORTED INCIDENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA UPON COMPLETION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED ON (B)(6) 2013 THAT THE CUSTOMER EXPERIENCED A COLLISION, AND THAT THE SYSTEM DOES NOT HAVE THE BUILT-IN PREVENTIVE COLLISION CONTROL THAT IT SHOULD. THERE IS NO REPORT OF MISTREATMENT OR INJURY TO A PATIENT AS THERE WAS NO PATIENT INVOLVEMENT IN THE INCIDENT. THIS REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123836 ARTISTE MV SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE SIEMENS MEDICAL SOLUTIONS USA, INC. 08139789

    Patients

    Seq Age Sex Outcome Treatment
    1