BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE STENOSCOPE

    MDR report key: 1051344 · Received May 6, 2008

    Report

    Report Number
    9617766-2008-01110
    Event Type
    Malfunction
    Date Received
    May 6, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE WAS REPLACED AND THE SOFTWARE RE-INSTALLED DURING THE SERVICE CALL. THE SYS WAS FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYS WOULD NOT BOOT UP. 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