BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1441343 · Received August 18, 2009

    Report

    Report Number
    1720753-2009-02873
    Event Type
    Malfunction
    Date Received
    August 18, 2009
    Date of Event
    March 13, 2009
    Report Date
    April 3, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. THE GE SERVICE REP FOUND THAT THE CONNECTOR WAS WORN. HE COULD NOT DUPLICATE THE COLLIMATOR ERROR. THE REP REPLACED THE VIDEO CABLE AND CONNECTOR. HE THEN PERFORMED A DIAGNOSTIC TESTING ON THE COLLIMATOR AND CALIBRATED THE COLLIMATOR IRIS STOPS. THE SYSTEM FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VIDEO CONNECTOR IN THE BACK OF THE WORK STATION WAS BROKEN. ALSO SYSTEM WAS BOOTED UP TO THE COLLIMATOR IRIS TO A LARGE ERROR. THE USER REBOOTED AND THE SYSTEM PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1