BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1820053 · Received August 23, 2010

    Report

    Report Number
    9617766-2010-00485
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE X-RAY TUBE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM STOPPED FLUOROING DURING A LUMBAR VERTEBRAE EXAM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1