BEUDAMED
    FDA Adverse Event Summary report: N

    XENON 300

    MDR report key: 3901522 · Received June 23, 2014

    Report

    Report Number
    3901522
    Date Received
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCT
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE DEVICE IS TURNED ON, THE MAIN CONSOLE DEFAULTS TO A LOW LEVEL HEAT SETTING RATHER THAN DEFAULTING TO A STANDBY MODE. THE CIRCULATOR OR OTHER OPERATING ROOM STAFF NEEDS TO SWITCH THE DEVICE TO STANDBY OR IT CONTINUES TO EMIT HEAT. THERE WAS A RECENT EVENT IN THE OR WHERE THE DEVICE WAS NOT SWITCHED TO STANDBY AFTER IT WAS TURNED ON AND THE DEVICE BURNED A HOLE IN A DRAPE ON THE OR TABLE. NO PATIENT HARM OCCURRED AT THE TIME. STAFF WOULD PREFER IF THE DEVICE DEFAULTED TO THE STANDBY SETTING RATHER THAN TO A HEATED SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366105 XENON 300 LIGHT SOURCE, ENDOSCOPE, XENON ARC GCT KARL STORZ ENDOSCOPY-AMERICA, INC. ALL MODELS *

    Patients

    Seq Age Sex Outcome Treatment
    1 *