BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1860018 · Received September 17, 2010

    Report

    Report Number
    9617766-2010-00534
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 17, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (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 SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENOSCOPE SYSTEM IMAGES WOULD DISPLAY INVERTED. 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 (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1