BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1843361 · Received September 22, 2010

    Report

    Report Number
    9617766-2010-00546
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    January 8, 2010
    Report Date
    September 22, 2010
    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

    A GE REP EVALUATED THE SYSTEM AND REPAIRED IT. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POOR IMAGE QUALITY, THE IMAGES HAVE NO DEFINITION. NO PT 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 (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1