BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYLOG 3000PLUS

    MDR report key: 4925919 · Received July 10, 2015

    Report

    Report Number
    9611500-2015-00127
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K08260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE DESCRIPTION OF THE EVENT, THE LOGFILE RETURNED AND THE RESULTS OF THE INVESTIGATION IN THE REPAIR SHOP 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 TURNING) 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 PRE USE CHECK AND THEREFORE WILL PREVENT FROM 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. NO INJURY REPORTED. THE DEVICE GENERATED AN ERROR MESSAGE/ALARM. FURTHER MEASURES WERE NOT TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED WHILE DURING USE AND GENERATED AN INOP ERROR MESSAGE. THE PATIENT WAS MANUALLY VENTILATED AND THE DEVICE WAS RESTARTED WITHOUT SUCCESS. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451057 OXYLOG 3000PLUS VENTILATORS, TRANSPORT CBK DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1