BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1002133 · Received February 25, 2008

    Report

    Report Number
    1720753-2008-16381
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE COLLIMATOR AND REPAIRED THE COLLIMATOR CONNECTOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR IRIS ON THE 9800 SYSTEM IS TOO LARGE. IT WAS NOTED THAT THE SYSTEM PRESENTED A POTENTIOMETER ERROR AT BOOT UP. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1