BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2191173 · Received July 19, 2011

    Report

    Report Number
    1720753-2011-20191
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CINE HARD DRIVE WAS REFORMATTED AND THE POWER CONNECTION CHECKED. THE CINE FUNCTIONS WERE CHECKED BY FLUORING IN CINE MODE AND SAVING AND REPLAYING CINE RUNS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CINE DISK ERROR MESSAGE. THE CASE WAS COMPLETED WITH ANOTHER SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1