BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERINFLATION

    MDR report key: 3109789 · Received May 2, 2013

    Report

    Report Number
    3109789
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE GREEN CAP COVERING THE SAMPLE PORT WAS MISSING ON THE FLOW INFLATING BAG. THE CAPS ARE CRACKED ON A MANUFACTURED SEAM AND FALLING OFF OF THE BAG. THIS HAS OCCURRED WITH ABOUT 15 BAGS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193519 HYPERINFLATION RESUSCITATOR, MANUAL BTM VENTLAB CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *