BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STENOSCOPE

    MDR report key: 1854603 · Received September 9, 2010

    Report

    Report Number
    9617766-2010-00515
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    July 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS HAVING A FLUOROSCOPY KV REGULATION PROBLEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENOSCOPE FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) STENOSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1