BEUDAMED
    FDA Adverse Event Death Summary report: N

    BABLOG 8000+

    MDR report key: 3030512 · Received March 20, 2013

    Report

    Report Number
    9611500-2013-00016
    Event Type
    Death
    Date Received
    March 20, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 20, 2013
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K903089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN CHECKED BY DRAEGER FSE AND THE REPORTED FLOW MEASUREMENT PROBLEM CAN BE CONFIRMED. AS THE EXCHANGE OF FLOW SENSOR AND FLOW SENSOR CABLE EARLIER PROVIDED BY THE USER HAS NOT SOLVED THE PROBLEM, THE FSE HAS REPLACED THE FLOW MEASUREMENT PCB OF THE VENTILATOR. THE LOG FILE ANALYSIS GAVE NO HINT TO THE EVENT. THE ROOT CAUSE FOR THE REPORTED SYMPTOM COULD NOT BE DETERMINED CONCLUSIVELY. THE PCB HAS BEEN RETURNED TO THE MFR AND FOUND FULLY FUNCTIONAL. A ONE-WEEK ENDURANCE TEST HAS NOT PRODUCED FURTHER RESULTS. IT IS SEEN LIKELY THAT THE PROBLEM IS ASSOCIATED TO THE FLOW SENSOR AND/OR THE FLOW SENSOR CABLE AS BOTH PRODUCTS ARE SUBJECT TO WEAR AND TEAR. UNFORTUNATELY, THE PARTS INVOLVED IN THE EVENT HAD BEEN DISPOSED BY THE USER FACILITY ALREADY. FINALLY IT IS CONCLUDED THAT THE DEVICE HAS DETECTED A DEVIATION AND RESPONDED TO IT AS SPECIFIED BY EXECUTING THE CORRESPONDING ALARM. THE TECHNICAL CONSEQUENCES OF THE REPORTED SYMPTOM WERE LIMITED TO DISTURBED FLOW MEASUREMENT. THE FLOW MEASUREMENT HAS MONITORING FUNCTION ONLY AND IS INDEPENDENT FROM THE CONTROL LOOP OF THE FLOW GENERATION. THE VENTILATION WAS CONTINUED WITHIN THE ADJUSTED PRESSURE LIMITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "FLOW MEASUREMENT-RELATED ALARMS OCCURRED REPEATEDLY. EXCHANGE OF FLOW SENSOR, SENSOR CABLE AND Y-PIECE DID NOT SOLVE THE PROBLEM. THESE MULTIPLE EXCHANGES OF FLOW MEASUREMENT COMPONENTS/ACCESSORIES HAVE CAUSED SEVERAL SHORT VENTILATION INTERRUPTIONS AND THUS, MAY HAVE RESULTED IN MULTIPLE ALVEOLAR DERECRUITMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116177 BABLOG 8000+ VENTILATOR, INTENSIVE CARE, NEONATAL/PEDIATRIC CBK DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death