BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBU SPUR

    MDR report key: 237698 · Received August 25, 1999

    Report

    Report Number
    237698
    Event Type
    Death
    Date Received
    August 25, 1999
    Date of Event
    August 10, 1999
    Report Date
    August 24, 1999
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN FULL CARDIAC ARREST; AND THE STAFF WAS PROVIDING INITIAL AIRWAY MANAGEMENT (IE BAG VALVE MASK) WHEN THEIR EFFORTS WERE HAMPERED BY A MISSING FACE MASK IN THE PACKAGE OF AMBU MANUAL SINGLE PATIENT USE RESUSCITATOR (SPUR). THE STAFF OPENED OTHER PACKAGES OF AMBU SPUR; AND A FACE MASK WAS FINALLY LOCATED IN THE 10TH PACKAGE. DURING THE SEARCH FOR A FACE MASK, THE PT WAS VENTILATED THROUGH ANOTHER MEANS. THE EFFORTS TO RESUSCITATE FAILED AND THE PT EXPIRED. FACE MASKS WERE MISSING IN A TOTAL OF 9 PACKAGES. THE AMBU SPUR IS PACKAGED IN AN OPAQUE BAG, WHICH MAKES IT DIFFICULT TO NOTICE ANY MISSING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR MANUAL SINGLE PATIENT USE RESUSCITATOR BTM AMBU INC. NA 98343 & MAYBE OTHERS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death