BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1930037 · Received December 2, 2010

    Report

    Report Number
    9617766-2010-00800
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 30, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE CONTACTED THE CUSTOMER BY PHONE, AND DIRECTED HIM TO REPLACE A TRANSISTOR ON A CIRCUIT BOARD. SYSTEM OPERATES AS INTENDED. NO GE SERVICE WAS NEEDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WILL NOT DISPLAY IMAGES OR PRODUCE X-RAYS. NO PATIENT 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