BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 2031090 · Received March 4, 2011

    Report

    Report Number
    9617766-2011-00531
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    November 11, 2010
    Report Date
    March 4, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WILL NOT DISPLAY AN IMAGE. 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) STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1