BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FABIUS GS

    MDR report key: 3231801 · Received July 5, 2013

    Report

    Report Number
    9611500-2013-00046
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    June 12, 2013
    Report Date
    July 1, 2013
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    BSZ
    PMA / PMN Number
    K011404
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE FRESH GAS HOSE IS NOT CONNECTED THE PRE USE CHECK WILL FAIL. THIS TEST IS REQUIRED TO BE PROCEEDED ACCORDING TO THE INSTRUCTIONS FOR USE ON A DAILY BASIS. IF THE FRESH GAS HOSE IS DISCONNECTED DURING A CASE THE VENTILATION WILL BE PERFORMED WITH ROOM AIR. DEPENDING ON THE OXYGEN UPTAKE FROM THE PATIENT AN INSPIRATORY OXYGEN LOW ALARM WILL BE POSTED IF THE SET ALARM LIMITS ARE EXCEEDED. THE LOWEST LIMIT THAT CAN BE SET IS 18%. THE LOGFILE OF THE FABIUS WAS SENT TO THE MFR FOR EVAL. THE LOGFILE INDICATED THAT AT 1:07 IN THE NIGHT A PRE USE CHECK WAS PERFORMED AND FAILED. LATER THAT DAY AT THE TIME OF THE REPORTED OCCURRENCE- THE FABIUS LOG FILE INDICATED A LOW OXYGEN CONCENTRATION (BELOW 10%). THIS ITEM IS RECORDED TWICE IN THE LOG WITHIN 2 MINUTES INTERVALS AND WILL LEAD TO A HIGH PRIORITY ALARM. AFTER FURTHER 8 MINUTES THE MESSAGE O2 LOW INOP IS ENTERED IN THE LOG. THERE EXISTS NO HINT TO A TECHNICAL DEVICE ERROR THAT ASSOCIATES TO THE REPORTED EVENT. PICTURES FROM THE ALARM LOGS WERE TAKEN AND ALSO SENT TO THE MFR. THE PICTURES WITH THE ENTRIES OF THE ALARM LOG WERE ANALYZED. THE ALARM LOG BOOK WAS CLEARED BEFORE THE INVESTIGATION COULD HAVE BEEN STARTED BY DRAGGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE USER FORGOT TO CONNECT THE FRESH GAS HOSE TO THE VENTILATION UNIT BECAUSE THE PREVIOUS CASE IT WAS OPEN SYSTEM CASE, THEN USER START NEXT OPERATION WITHOUT CONNECTION OF THE FRESH GAS HOSE TO THE VENTILATION UNIT COSY, WHICH LED TO A BRAIN DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308656 FABIUS GS ANAESTHESIA WORKSTATION BSZ DRAEGER MEDICAL AG & CO. KG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening