BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 853030 · Received May 21, 2007

    Report

    Report Number
    1720753-2007-01028
    Event Type
    Malfunction
    Date Received
    May 21, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 21, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND A DEFECTIVE HIGH VOLTAGE (HV) CABLE TO THE IRIS COLLIMATOR. THE HV CABLE WAS REPLACED AND DURING SERVICE, IT WAS NOTED THAT GROING HAD DAMAGED THE CATHODE CABLE. THE HV CABLE WAS REPLACED ALSO, IN ADDITION TO THE X-RAY TUBE. THE COLLIMATOR WAS ALIGNED AND CALIBRATED. THE SYSTEM WAS TESTED AND RECALIBRATED AND OPERATES AS INTENDED. THE SYSTEM WAS RELEASED TO THE CUSTOMER FOR USE. THERE WAS NOT REPORTED INJURY OR NEGATIVE EFFECT TO ANY PATIENT AS A RESULT OF THIS MALFUNCTION. THE FACILITY WAS UNABLE OR WOULD NOT PROVIDE ANY PATIENT INFORMATION WITH RESPECT TO THIS ISSUE.

    Description of Event or Problem · 1

    THE GE OEC 9800 FLUOROSCOPY SYSTEM DISPLAYED IRIS POT ERROR. THE ERROR COULD NOT BE CLEARED AND THE SYSTEM WAS INOPERABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR