BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSTAR 2

    MDR report key: 1220656 · Received October 31, 2008

    Report

    Report Number
    9680959-2008-00210
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 30, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPC CARD WAS RESEATED BUT THE SAME SYMPTOM OCCURRED. THE SERVICE ENGINEER IS SCHEDULED TO REPLACE THE HARD DRIVE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AFTER SEVERAL MINUTES OF USING THE SYSTEM, AN ERROR OCCURRED AND THEY HAD TO REBOOT THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSTAR 2 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1