BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 3983299 · Received July 1, 2014

    Report

    Report Number
    2246980-2014-00003
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 1, 2014
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VALUE FAILED DURING PATIENT USE. DOCTOR WAS ATTEMPTING TO USE RESUS BAG AND PREPARING TO BE INTUBATED. NO SERIOUS INJURY OR DEATH INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383679 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB CORP. AF5140MB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1