BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2101644 · Received May 11, 2011

    Report

    Report Number
    9617766-2011-01026
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GE MED SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE RECOMMENDED THAT A COMPONENT IN THE POWER SUPPLY BE REPLACED BEFORE USING THE SYSTEM. HOWEVER, THE SYSTEM IS FUNCTIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS SMOKE COMING FROM THE SYSTEM'S CONSOLE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1