BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2102772 · Received May 23, 2011

    Report

    Report Number
    9617766-2011-01103
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 23, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT POOR IMAGE QUALITY PREVENTS THE SYSTEM FROM BEING USED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOP FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1