BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600+

    MDR report key: 1172999 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26098
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DIAGNOSED PROBLEM AND REPLACED THE X-RAY REGULATOR PCB, AND TURNED SYSTEM OVER TO BIOMED FOR RE-ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600+ FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1