BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW SMALL ADULT RESUSCITATOR

    MDR report key: 3212895 · Received April 2, 2013

    Report

    Report Number
    2246980-2013-00003
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    April 1, 2013
    Manufacturer
    VENTLAB LLC
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULTS: PRODUCT NOT RETURNED FOR EVAL. ENGINEERING PERFORMING TOLERANCE STACK-UP.

    Description of Event or Problem · 1

    WHEN USING THE AMBU BAG ON A PT, IT WAS DISCOVERED THAT THE RESERVOIR BAG WAS DEFLATED AND UPON FURTHER INSPECTION IT WAS DETERMINED THE TUBING FROM THE OXYGEN SOURCE WAS NOT CONNECTED TO THE AMBU BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135618 AIRFLOW SMALL ADULT RESUSCITATOR VENTILATOR, EMERGENCY, MANUAL (RESUS) BTM VENTLAB LLC AF5040MB 105181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention