BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU SPUR II ADULT RESUSCITATOR

    MDR report key: 2303270 · Received October 18, 2011

    Report

    Report Number
    MW5022687
    Event Type
    Injury
    Date Received
    October 18, 2011
    Date of Event
    September 22, 2011
    Report Date
    September 23, 2011
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEW AMBU BAG WAS REMOVED FROM PACKAGING AND WAS ATTACHED TO PATIENT AND OXYGEN SOURCE. BAG FAILED TO FILL AND DID NOT FUNCTION. REPLACEMENT BAG OBTAINED FOR PATIENT. AFTER EVENT THE BAG WAS EXAMINED AND A SEAM WAS FOUND TO BE DEFECTIVE. REASON FOR USE: DECREASE IN OXYGEN SATURATION LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR II ADULT RESUSCITATOR ADULT AMBU BAG BTM AMBU, INC. SPUR II ADULT RESUSCITATOR 1328692

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention