BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 1973702 · Received January 17, 2011

    Report

    Report Number
    9617766-2011-00075
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 17, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM, BUT REPLACED THE COMPLETE SET OF CABLES AS A PRECAUTIONARY MEASURE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE X-RAY OUTPUT WAS UNSTABLE. 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. STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1