BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9600

    MDR report key: 1172995 · Received September 19, 2008

    Report

    Report Number
    1720753-2008-26079
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE COLLIMATOR. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT COMPLETE BOOT UP, DISPLAYING IRIS POT ERROR. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1