BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1930067 · Received December 2, 2010

    Report

    Report Number
    9617766-2010-00805
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 20, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE ARO. A GE REP EVALUATED THE SYSTEM AND REPLACED THE FOOT PEDAL. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM PRODUCES X-RAYS ON ITS OWN. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1