BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1921818 · Received December 8, 2010

    Report

    Report Number
    9617766-2010-00821
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    October 24, 2009
    Report Date
    December 8, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND TIGHTENED LOOSE SCREWS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE COLLIMATOR. 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