BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYLOG 3000

    MDR report key: 4992333 · Received July 28, 2015

    Report

    Report Number
    9611500-2015-00148
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 28, 2015
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K062267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DESCRIPTION OF THE EVENT AND THE LOGFILE RETURNED PROVIDED A BASIS FOR THE INVESTIGATION. THE REPORTED ISSUE COULD BE REPRODUCED AS THE LOG SHOWED AN ENTRY FOR THE ALARM MESSAGE "POTI UNPLUGGED". THIS MESSAGE AND AN ACOUSTICAL AND VISUAL ALARM ARE GENERATED IF THE VALUE OF ONE OF THE FRONT POTENTIOMETERS IS BEYOND SPECIFICATION. UNDER THIS CONDITION VENTILATION WILL STOP. THE REASON FOR THE BEHAVIOR IS THAT AFTER A LONGER TIME OF NOT ADJUSTING (NOT TUNING) A POTENTIOMETER AT THE FRONT PANEL, A THIN OXIDE LAYER CAN DEVELOP, RESULTING IN CONTACT PROBLEMS WHEN THE POTENTIOMETER IS FINALLY MOVED. IN THE COURSE OF CONTINUOUS PRODUCT IMPROVEMENT A NEW SOFTWARE VERSION WAS ALREADY RELEASED WHICH REQUIRES ADJUSTING THE POTENTIOMETER DURING DEVICE PRO USE CHECK AND THEREFORE WILL REDUCE THE RISK OF REOCCURRENCE OF THIS FAILURE. THIS SOFTWARE IS INSTALLED BY DRAGER SERVICE DURING THE REGULAR DEVICE MAINTENANCE. A TRANSPORT VENTILATOR IS ALWAYS USED UNDER CLOSE OBSERVATION OF THE USER. IT IS DESCRIBED IN THE "INSTRUCTIONS FOR USE" TO KEEP AVAILABLE AT ANY TIME AN ALTERNATIVE VENTILATION DEVICE AS BACKUP. THE INVESTIGATOR RECOMMENDS TO CHANGE THE FRONT PANEL AND TO UPDATE THE SOFTWARE. THIS SYMPTOM IS ADDRESSED IN A PRODUCT CAPA. THE RESIDUAL RISK IS ASSESSED AS BEING ACCEPTABLE BY THE RESPONSIBLE PRODUCT BOARD. AN INJURY WAS NOT REPORTED. THE DEVICE GENERATED AN ERROR MESSAGE/ALARM. THE INVESTIGATION REPORT RECOMMENDS TO REPLACE THE FRONT PANEL.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS ALREADY STARTED RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED: THE DEVICE FAILED TOWARDS THE END OF AN INNER-CLINICAL PATIENT TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492302 OXYLOG 3000 VENTILATORS, TRANSPORT CBK DRAEGER MEDICAL GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1