BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE CSTAT 3000

    MDR report key: 1152483 · Received September 10, 2008

    Report

    Report Number
    1225258-2008-00012
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 10, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE CALL WAS CANCELLED BY THE CUSTOMER. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CSTAT 3000 SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE CSTAT 3000 RADIOLOGICAL IMAGE PROCESSING SYSTEM LLZ GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1