BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2030581 · Received March 9, 2011

    Report

    Report Number
    9617766-2011-00568
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 9, 2011
    Manufacturer
    GE MED SYS (INDIA) PRIVATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPAIRED A CONNECTOR ON THE HARD DRIVE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL NOT HOLD AN IMAGE ON SCREEN AFTER RELEASING THE FOOT PEDAL. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1