BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS

    MDR report key: 4612190 · Received March 10, 2015

    Report

    Report Number
    4612190
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    December 11, 2014
    Report Date
    January 9, 2015
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE AIR CUSHION ON THE MASK FAILED TO INFLATE WHEN ATTEMPTING TO VENTILATE THE PATIENT USING THE ADULT FACE MASK (#5). DESPITE MULTIPLE ADJUSTMENTS WITH PATIENT POSITIONING, CHANGING THE LONG VALVE MASK TWICE AND CHANGING OF THE JACKSON REESE CIRCUIT, THE BAG SIMPLY WOULD NOT INFLATE INDICATING A LEAK SOMEWHERE IN THE CIRCUIT.AN AMBU BAG WAS IMMEDIATELY AVAILABLE AND THE PATIENT WAS VENTILATED WITHOUT ISSUE. THE TROUGH OXYGEN SATURATION WAS 26% AND CAME BACK UP TO 99% OVER TWO MINUTES.UPON INSPECTION OF THE EQUIPMENT, THE MASK WAS DEFLATED AND WOULD NOT INFLATE WITH SYRINGE; THE AIR WOULD SIMPLY LEAK OUT. THUS, WE CONCLUDED THE DEFECTIVE MASK WAS THE CAUSE OF NOT BEING ABLE TO OBTAIN A SEAL.SEVERAL MORE MASKS OF THE SAME BRAND (A BRAND WE DO NOT REGULARLY USE AS ANESTHESIOLOGISTS; DIFFERENCE IS WITH THE LONG VALVE INFLATION MECHANISM) AND HAD THE SAME ISSUE OF NOT BEING ABLE TO INFLATE THE MASK WITH AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163995 VITAL SIGNS MASK, VENTILATOR BYX CAREFUSION 211, INC.. DBA CAREFUSION * 7732982

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR AND CHANGING OF THE JACKSON REESE CIRCUIT, THE| NO OTHER THERAPIES| SOMEWHER IN THE CIRCUIT.| DESPITE MULTIPLE ADJUSTMENTS WITH PATIENT| POSITIONING, CHANGING THE LONG VALVE MASK TWICE| BAG SIMPLY WOULD NOT INFLATE INDICATING A LEAK