BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 5989916 · Received September 30, 2016

    Report

    Report Number
    5989916
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    August 24, 2016
    Report Date
    September 2, 2016
    Manufacturer
    VENTLAB CORPORATION, LLC
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE USED THIS PRODUCT SEVERAL TIMES AND THE MASK WAS VERY DIFFICULT (IMPOSSIBLE WITH SOME) TO REMOVE FROM THE RESUSCITATOR ITSELF. WE HAD TO RUN AND GET ANOTHER RESUSCITATOR AFTER INTUBATING A PATIENT IN ORDER TO MANUALLY VENTILATE THE PATIENT. SEVERAL TIMES WE ACTUALLY CRACKED THE VALVE ON THE RESUSCITATOR BAG TRYING TO REMOVE THE MASK. NO PATIENT HARM BECAUSE WE WERE ABLE TO FIND ANOTHER RESUSCITATOR. MANUFACTURER RESPONSE FOR RESUSCITATOR BAG, AIRFLOW (PER SITE REPORTER): THEY SAID THEY CHANGED THE MOLD ON THE MASK AND WILL REPLACE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642548 AIRFLOW VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VENTLAB CORPORATION, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1