BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1820062 · Received August 23, 2010

    Report

    Report Number
    1720753-2010-02718
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE MAINFRAME 5V POWER SUPPLY, RESEATED THE POWER SUPPLY CABLE, ADJUSTED THE ISOLATION TRANSFORMER TAPS, ERASED FFB, GIB, AND SRV FLASH, AND RESTORED ALL CALIBRATION FILES. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT PRODUCE X-RAYS. 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