BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPUR II

    MDR report key: 3021120 · Received March 21, 2013

    Report

    Report Number
    3021120
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 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

    PEDIATRIC PATIENT NEEDED ASSISTANCE WITH BREATHING WITH AMBU BAG. ANESTHESIOLOGIST ATTEMPTED TO USE AMBU BAG TO VENTILATE PATIENT AND AMBU BAG DID NOT FUNCTION PROPERLY. THE PHYSICIAN THINKS THERE WAS A LEAK IN THE BAG. AMBU BAG WAS SWITCHED IMMEDIATELY WITH NO PATIENT HARM. THIS IS THE SECOND OCCURRENCE WITH THIS DEVICE IN LESS THAN ONE MONTH. ======================MANUFACTURER RESPONSE FOR AMBU SPUR II PEDIATRIC RESUSCITATOR, AMBU (PER SITE REPORTER).======================I AWAIT RESPONSE IF THEY WOULD LIKE US TO SHIP FOR FURTHER INVESTIGATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PEDIATRIC VENTILATION POST SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118777 SPUR II VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM AMBU, INC * 1424605

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR