BEUDAMED
    FDA Adverse Event Death Summary report: N

    FABIUS GS

    MDR report key: 2655045 · Received June 29, 2012

    Report

    Report Number
    9611500-2012-00038
    Event Type
    Death
    Date Received
    June 29, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    BSZ
    PMA / PMN Number
    K011404
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTS PERFORMED BY THE HOSPITALS BIOMEDS REVEALED THAT THE LEAKAGE TEST COULD NOT BE PERFORMED SUCCESSFULLY. THE DEVICE DID NOT PASS THIS TEST. THE VAPORIZER FITTINGS FOUND A GOOD CONDITION. FURTHER INVESTIGATION SHOWED A BROKEN EXPIRATORY FLOW SENSOR TO CAUSE THE TEST TO FAIL. LAST LEAKAGE TEST WAS PERFORMED ON (B)(6). THE IFU REQUIRES TO CARRY OUT A LEAKAGE TEST BEFORE EACH DAILY USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DRAGER THAT: THE PT MONITORING INDICATED A DELIVERY OF LOW OXYGEN CONCENTRATION TO THE PT. IDENTIFIED FAULTS WERE LEAKS IN PT VENTILATION CIRCUIT FROM POORLY FITTED VAPOURISER AND/OR DAMAGED FLOW CENSOR. IT WAS REPORTED THAT THE PT DIED LATER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FABIUS GS ANESTHESIA UNIT BSZ DRAEGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1