BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELSTAR IMAGING SYSTEM

    MDR report key: 603676 · Received May 16, 2005

    Report

    Report Number
    3003084417-2005-00006
    Event Type
    Malfunction
    Date Received
    May 16, 2005
    Date of Event
    March 15, 2005
    Report Date
    May 11, 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 FLUOROSCOPY WAS WORKING INTEMITTENTLY WHEN THE FLUOROSCOPY PEDAL WAS DEPRESSED, NOT ALLOWING X-RAY IMAGES ON THE SCREEN WITH A PT ON THE FLUOROSCOPY TABLE. THE SYSTEM WAS REBOOTED AND THE SYSTEM WORKED. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE.

    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