BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU SPUR II

    MDR report key: 2992187 · Received February 28, 2013

    Report

    Report Number
    2992187
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APNEIC CHILD ARRIVED TO PACU AND REQUIRED AMBU VENTILATION. ANESTHESIOLOGIST WAS ATTEMPTING TO VENTILATE PATIENT WITH PEDIATRIC AMBU BAG AND STATED THERE WAS A LEAK WHICH MADE IT UNABLE TO VENTILATE PROPERLY. UNABLE TO FIND SOURCE OF LEAK IN BAG. NEW PEDIATRIC AMBU BAG IMMEDIATELY BROUGHT TO BEDSIDE.PACU CLINICAL LEADER STATES SHE HAS NOT HEARD OF THIS HAPPENING BEFORE. CHILD WOKE UP APPROPRIATELY AND WAS LATER DISCHARGED HOME AFTER MEETING DISCHARGE CRITERIA.======================MANUFACTURER RESPONSE FOR AMBU SPUR II PEDIATRIC RESUSCITATOR, AMBU (PER SITE REPORTER).======================LEFT A MESSAGE IN THE QUALITY DEPARTMENT AND AWAIT A CALL BACK. PLAN TO RETURN TO MANUFACTURER FOR INVESTIGATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VENTILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87223 AMBU SPUR II VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU, INC. * 1393806

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR