BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4820877 · Received June 3, 2015

    Report

    Report Number
    1720753-2015-02327
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 3, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM WOULD NOT SAVE IMAGES, LOCKED UP AND WAS HARD TO SHUT DOWN. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358051 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900 ES-2010

    Patients

    Seq Age Sex Outcome Treatment
    1