BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPUR II

    MDR report key: 2241068 · Received April 23, 2010

    Report

    Report Number
    2241068
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 16, 2010
    Report Date
    April 23, 2010
    Manufacturer
    AMBU, INC
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PROVIDING POSITIVE PRESSURE VENTILATION TO AN INFANT, INADEQUATE PRESSURE WAS NOTED ON THE MANOMETER WITH INADEQUATE RISE & FALL OF CHEST EVEN AFTER MULTIPLE ATTEMPTS IN REPOSITIONING THE INFANT. THE POP OFF VALVE WAS OCCLUDED & HIGHEST PRESSURE ON MANOMETER WAS 8 - 10 CM WATER (H2O). THE INFANT WAS SUBSEQUENTLY INTUBATED. STAFF HAD ATTACHED AMBU BAG TO REUSABLE MANAOMETER BY CUTTING ENDS OF TUBING. THIS IS NOT WHAT IS PROVIDED IN THE MANUFACTURER'S DIRECTIONS FOR USE ON PG. 10. THIS IS THE FIRST TIME A PROBLEM HAS BEEN NOTED WHEN THE PRODUCT HAS BEEN USED AS DECRIBED ABOVE.======================HEALTH PROFESSIONAL'S IMPRESSION======================PHYSICIAN WAS UNABLE TO USE THE DEVICE TO PROVIDE ADEQUATE VENTILATION.======================MANUFACTURER RESPONSE FOR RESUSCITATOR, AMBU SPUR II======================ASSISTED FACILITY IN GETTING A REPLACEMENT PRODUCT, VENDOR IS ASSISTING WITH NEW PRODUCT EDUCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPUR II RESUSCITATOR BTM AMBU, INC * 1108125

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY NO OTHER THERAPIES