BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYLOG 3000PLUS

    MDR report key: 7825909 · Received August 29, 2018

    Report

    Report Number
    9611500-2018-00276
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 14, 2018
    Report Date
    September 5, 2018
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K103625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A PATIENT TRANSPORT THE OXYLOG 3000PLUS WAS NOT VENTILATING. ACCORDING TO THE LOGFILE-ANALYSIS DONE BY THE SERVICE ENGINEER AND ADDITIONALLY AT DRAEGER LÜBECK, THE DEVICE WAS TESTED PRIOR TO USE SUCCESSFULLY. INSPIRATORY GAS WAS SET TO 100% OXYGEN. THE DEVICE STARTED TO VENTILATE BY SELECTING THE HOSE SYSTEM. THE CONNECTED HOSE SYSTEM WAS A DISPOSABLE ONE, ALTHOUGH AT THE DEVICE SETTINGS A REUSABLE HOSE SYSTEM WAS SELECTED. THIS MEANS THAT THE EXPIRATORY FLOW MEASUREMENT IS BASED ON THE FLOW SENSOR CHARACTERISTICS FOR THE REUSABLE HOSE SYSTEM AND ARE CONSEQUENTLY CALCULATED WRONGLY. THE DISPLAYED MINUTE VOLUME IS ACCORDINGLY LOWER THAN THE ACTUAL APPLIED VOLUME. THE LOGFILE SHOWS THAT THE EXPIRATORY MINUTE VOLUME (MVE) WAS THE MINIMUM AT 4,5 L/MIN AS THE USER SET THE LOWER ALARM LIMIT FOR MVE TO 4,5 L/MIN. THE INSTRUCTIONS FOR USE STATES AS A WARNING THAT THE ALARM LIMITS HAS TO BE SET CAREFULLY AND THAT THERE IS A RISK OF INADEQUATE PATIENT VENTILATION. THE MINIMUM MINUTE VOLUME REQUIRED BY THE PATIENT MUST BE MONITORED VIA THE LOWER ALARM LIMIT MVE. THERE IS NO INDICATION OF A MALFUNCTION OF THE DEVICE. THE INSTRUCTIONS FOR USE STATES CLEARLY HOW TO PREPARE THE DEVICE AND HOW TO TAKE IT INTO USE.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL-REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WOULD SEEM THAT AT AROUND 15:00 ¿ 15:30 ON (B)(6) 2018, A PATIENT WAS TRANSPORTED FROM THEATRES TO ICU. UPON ARRIVAL TO ICU, IT WAS FOUND THAT THE OXYLOG WAS NOT VENTILATING. THE CLINICAL STAFF HAVE ASSERTED THAT THE OXYLOG WAS CHECKED AND CONFIRMED TO BE VENTILATING PRIOR TO TRANSPORT OCCURRING. IT WAS REPORTED THAT THE PATIENT IS IN A SERIOUS CRITICAL CONDITION IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667559 OXYLOG 3000PLUS VENTILATORS, TRANSPORT CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization