BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1140864 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24320
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP WAS UNABLE TO REPRODUCE THE ERRORS. HE WENT THROUGH THE STATOR CIRCUIT AND RE-SEATED BOARDS AND CONNECTIONS. NO PROBLEM FOUND. HE REPLACED THE IRIS POTENTIOMETER AND TESTED. THE SYSTEM IS OPERATING WITHOUT ERRORS AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IRIS AND STATOR NOT ON ERROR DURING A CASE. 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