BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC STENOSCOPE

    MDR report key: 1182718 · Received September 25, 2008

    Report

    Report Number
    9617766-2008-01323
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CAMERA NEEDED TO BE REPLACED. THE CUSTOMER CANCELED THE SERVICE CALL. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYSTEM HAD POOR IMAGE QUALITY. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1