BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELSTAR IMAGING SYSTEM

    MDR report key: 596086 · Received April 21, 2005

    Report

    Report Number
    3003084417-2005-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2005
    Date of Event
    March 3, 2005
    Report Date
    April 20, 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

    SITE STAFF MEMBER REPORTED THE COMPUTER MOUSE ON THE TELSTAR X-RAY UNIT FROZE, NOT ALLOWING SYSTEM USE. THE SYSTEM WAS REBOOTED. DIGITAL SERIES WAS REPEATED. IMAGES FROM PREVIOUS NEUROANGIOGRAPHIC DIGITAL SERIES PROCEDURES WERE SEEN MIXED IN WITH THE NEUROANGIOGRAPHIC DIGITAL SERIES CURRENTLY BEING PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.

    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