BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2041397 · Received March 23, 2011

    Report

    Report Number
    1720753-2011-02720
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD, FLUORO FUNCTIONS BOARD, AND THE INTERCONNECT CABLE WERE REPLACED. THE SERVICE REPRESENTATIVE ALSO REPAIRED WIRES IN THE COLUMN. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED. THIS EVENT MAY BE AN ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD X-RAY WHEN THE BUTTON WAS NOT BEING PUSHED. 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