BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYLOG

    MDR report key: 3881163 · Received February 7, 2014

    Report

    Report Number
    9611500-2014-00019
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 6, 2014
    Report Date
    February 7, 2014
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K062267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. WE WILL PROVIDE RESULTS WITH A IN SEPARATE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IN-HOUSE TRANSPORT TO THE OPERATING THEATRE THE PATIENT TURNED BLUE. HIGH CO2 WAS MEASURED. THE OXYLOG DID NOT SHOW A VENTILATION CURVE. THE DEVICE REPORTEDLY DID NOT ALARM. AFTER THE EVENT THE OXYLOG WAS USED FOR THE TRANSPORT BACK AND OPERATING PROPERLY. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80674 OXYLOG NONE CBK DRAEGER MEDICAL GMBH 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other