BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELSTAR IMAGING SYSTEM

    MDR report key: 615978 · Received June 2, 2005

    Report

    Report Number
    3003084417-2005-00007
    Event Type
    Malfunction
    Date Received
    June 2, 2005
    Date of Event
    May 6, 2005
    Report Date
    June 2, 2005
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMAGES OF A PREVIOUS PATIENT APPEARED ON A DIGITAL ANGIOGRAM OF THE PATIENT BEING TREATED. THEY WERE MIXED IN WITH THE CURRENT DIGITAL SERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELSTAR IMAGING SYSTEM DIGITAL IMAGING SYSTEM MQB STEREOTAXIS, INC. 030-000915-1 0004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other