BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FABIUS GS

    MDR report key: 1933976 · Received November 19, 2010

    Report

    Report Number
    9611500-2010-00046
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 19, 2010
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K011404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. RELEVANT COMPONENTS WERE REQUESTED FOR INVESTIGATION, BUT NOT YET RECEIVED. THE INVESTIGATION RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: THE FLOAT INSIDE THE ROTAMETER DELIVERING FRESH GAS TO THE PATIENT WAS BLOCKED. THE PATIENT DESATURATED AND BEGAN TO 'WAKE UP' AS DELIVERY OF OXYGEN AND ANAESTHETIC AGENT WAS RESTRICTED. THE PATIENT WAS ANAESTHETISED USING INTRAVENOUS MEDICATION AND VENTILATED WITH AN AUXILLIARY OXYGEN SUPPLY VIA A SELF-INFLATING BAG. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS GS ANAESTHESIA MACHINE BSZ DRAGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention