BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOP

    MDR report key: 2101658 · Received May 11, 2011

    Report

    Report Number
    9617766-2011-01023
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GE MED SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER ON THE CIRCUIT CONTACT AND THE TIMER SETTINGS WERE REPAIRED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM MADE A BANGING NOISE AND WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOP FLUOROSCOPIC X-RAY JAA GE MED SYSTEMS (INDIA) PRIVATE LTD STENOSCOP

    Patients

    Seq Age Sex Outcome Treatment
    1