BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2043438 · Received March 28, 2011

    Report

    Report Number
    1720753-2011-02912
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 28, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE OR LOCATE THE ERROR. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 9900 SYSTEM PRODUCED AN ERROR MESSAGE AND THE COLLIMATOR CLOSED DOWN INDEPENDENTLY. NO PATIENT 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