BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE STENOSCOPE

    MDR report key: 1051342 · Received May 6, 2008

    Report

    Report Number
    9617766-2008-01105
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 2, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CONFIGURATION BOARD WAS REPLACED DURING THE SERVICE CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYS SHUT DOWN DURING A CASE. THE SYS HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1