BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CSTAT 2000

    MDR report key: 1252863 · Received December 9, 2008

    Report

    Report Number
    1225258-2008-00011
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 4, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CSTAT 2000 SYSTEM LOCKED UP PRIOR TO A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE CSTAT 2000 RADIOLOGICAL IMAGE PROCESSING SYSTEM LLZ GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1