BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 896466 · Received August 14, 2007

    Report

    Report Number
    1720753-2007-03998
    Event Type
    Malfunction
    Date Received
    August 14, 2007
    Date of Event
    April 23, 2007
    Report Date
    August 14, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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. INVESTIGATION IDENTIFIED THAT THE IRIS WAS KNOCKED OUT OF ITS BRASS BEARINGS AND CLUTCH ON IRIS MOTOR SLIPPING, ALONG WITH A BAD IRIS POT. REPLACED BROKEN PARTS AND REPAIRED OTHER ASSEMBLIES. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM DISPLAYED A BAD IRIS POT ERROR. CUSTOMER ALSO REPORTED A BROKEN CROSS ARM BRAKE HANDLE AND STUCK FOOT SWITCH. THERE WAS NO REPORT OF ANY PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR