BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT RESUSCITATOR

    MDR report key: 1952313 · Received December 14, 2010

    Report

    Report Number
    1952313
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ROOM WAS BEING SET UP FOR A POST-OPERATIVE PATIENT. THE AMBU BAG WAS REMOVED FROM ITS PACKAGE AND WAS FOUND TO BE GLUED TO THE TUBING, MAKING IT NONFUNCTIONAL. ======================HEALTH PROFESSIONAL'S IMPRESSION======================AMBU BAG WAS FOUND TO BE GLUED TO THE TUBING WHEN BAG WAS REMOVED FROM THE PACKAGING. GLUED AREA HOLE WAS PRESENT IN THE TUBING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT RESUSCITATOR VENTILATOR, MANUAL, RESUSCITATOR BTM VENTLAB CORPORATION * 86375

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR NO OTHER THERAPIES