BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1900410 · Received October 26, 2010

    Report

    Report Number
    9617766-2010-00672
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    April 28, 2010
    Report Date
    October 26, 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 COLLIMATOR WAS CALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED. THIS INCIDENT MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S DOSE RATE WAS OUT OF COMPLIANCE. NO REPORT OF PATIENT OR STAFF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1