BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1781133 · Received July 29, 2010

    Report

    Report Number
    1720753-2010-02226
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE AND RELOADED SOFTWARE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE MONITOR IS NOT WORKING AND THE SYSTEM WILL NOT SAVE IMAGES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 C-ARM JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1