BEUDAMED
    FDA Adverse Event Death Summary report: N

    FABIUS GS

    MDR report key: 4950066 · Received July 23, 2015

    Report

    Report Number
    9611500-2015-00144
    Event Type
    Death
    Date Received
    July 23, 2015
    Date of Event
    May 21, 2014
    Report Date
    August 28, 2015
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K011404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    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 AND ADDITIONAL INFORMATION RECEIVED PROVIDED A BASIS FOR THE INVESTIGATION. NEITHER LOGFILES FROM THE TIME OF THE EVENT NOR SUSPECTED PARTS WERE AVAILABLE ANYMORE AS THE EVENT OCCURRED MORE THAN ONE YEAR AGO AND THE LOGS WERE OVERWRITTEN. THE INVESTIGATION WAS DONE ON THE BASIS OF THE INFORMATION PROVIDED BY THE SERVICE TECHNICIANS. AFTER THE INCIDENT THE TECHNICIANS FOUND WORN MEMBRANES AND A LEAK IN THE FLOWMETER. WORN MEMBRANES WOULD CAUSE LEAKAGE. INSUFFICIENT AUTOMATIC VENTILATION MAY BE THE CONSEQUENCE. HOWEVER, LEAKAGE WITHIN THE VALVES OF THE BREATHING SYSTEM WOULD BE IDENTIFIED DURING THE LEAKAGE AND COMPLIANCE TEST AS PART OF THE PRE-USE CHECK. ON THE DAY OF EVENT THE LEAKAGE AND COMPLIANCE TEST WAS NOT PERFORMED. IN ADDITION TO THAT A LEAKAGE ALARM AS "EXP.PORT LEAK" AND ALARMS RELATED TO APNEA, PRESSURE, MINUTE VOLUME AND OXYGEN CONCENTRATION WILL BE GENERATED. DEPENDING ON THE LOCATION OF THE LEAKAGE WITHIN THE PATIENT SYSTEM MANUAL VENTILATION WITH AN ALTERNATE DEVICE MAY CONSIDERED NECESSARY. DEPENDING ON ITS LOCATION A LEAK IN THE FLOWMETER WILL CAUSE A DECREASED FRESH GAS LEVEL OR A DEVIATION BETWEEN THE FRESH GAS DISPLAY AND THE FLOWMETER. A DECREASED FRESH GAS AND OXYGEN LEVEL WILL BE DETECTED AND ACCORDINGLY ALARMED BY THE INTERNAL OXYGEN SENSOR VIA "INSP O2 LOW" AND "FRESH GAS LOW" RESPECTIVELY. MANDATORY EXTERNAL PATIENT GAS AND AGENT MONITORING WILL PROVIDE ACTUAL CONCENTRATIONS OF OTHER ESSENTIAL GASES. THE INTERNAL O2 MONITORING, THE VOLUME MEASUREMENT AND THE EXTERNAL MONITORING WOULD HAVE DETECTED AND ACCORDINGLY ALARMED A POTENTIAL HYPOXIA. CONCLUSION: IN THIS HOSPITAL THE DEVICE IS INSPECTED BY DRÄGER AND RECOMMENDATIONS FOR MAINTENANCE ARE GIVEN. THE CUSTOMER MAY AGREE. THE CONCERNED MEMBRANES WERE FOUND TO BE OVERDUE FOR REPLACEMENT. THE INVESTIGATION IS LIMITED AS NEITHER PARTS NOR LOGFILE WERE AVAILABLE. HOWEVER THE EFFECTS ARE LEAKAGES WHICH WOULD HAVE LED TO MEDIUM RESPECTIVELY HIGH PRIORITY ALARMS INFORMING THE OPERATOR ABOUT A POTENTIAL DEVIATION. THE LEAKAGE AND COMPLIANCE TEST WHICH WOULD HAVE IDENTIFIED LEAKAGE CAUSED BY WORN MEMBRANE WAS REPORTEDLY NOT DONE ON THE DAY OF EVENT.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014 DURING VENTILATION WITH FABIUS GS A PATIENT DIED. ON (B)(6) 2014 OUR SERVICE TECHNICIAN (B)(6) CHECKED THE DEVICE AND FOUND WORN MEMBRANES AND SEALING WASHERS IN PT SYSTEM. HE WAS NOT INFORMED ABOUT THE PT DEATH AT THAT TIME. ON (B)(6) 2014 DRAGER WAS INFORMED ABOUT AN INVESTIGATION STARTED BY THE PUBLIC ATTORNEY.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL REPORT

    Description of Event or Problem · 1

    ON 07/14/2015, DRAGER WAS INFORMED ABOUT AN INVESTIGATION STARTED BY THE PUBLIC ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480239 FABIUS GS ANESTHESIA UNITS CBK DRÄGERWERK AG & CO. KGAA UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death