BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2062406 · Received April 12, 2011

    Report

    Report Number
    9617766-2011-00893
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    November 30, 2010
    Report Date
    April 12, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR COVER WAS REPLACED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE HARD DRIVE AND THE X-RAY TUBE COVER ON THE STENOSCOP SYSTEM. NO PATIENT 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