BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1860428 · Received September 27, 2010

    Report

    Report Number
    9617766-2010-00558
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 27, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MONITOR AND POWER CABLE WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S MONITOR CONTINUED TO SHUT ITSELF OFF. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOPE FLUROSCOPY XRAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1