BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1781146 · Received July 29, 2010

    Report

    Report Number
    9617766-2010-00410
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    May 13, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A CIRCUIT BREAKER. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM TURNS ON AND SHUTS DOWN ON ITS OWN. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1