BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2935188 · Received January 28, 2013

    Report

    Report Number
    1720753-2013-01110
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 28, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. A SYSTEM CABLE WAS REPLACED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYS WAS UNABLE TO PRODUCE X-RAY. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38132 STENOSCOP FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1