BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4226789 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00021
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 25, 2013
    Report Date
    September 19, 2014
    Manufacturer
    VENTLAB
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BELATED MDR IS BEING SUBMITTED AS PART OF OUR REMEDIATION EFFORTS IN RESPONSE TO THE FDA FORM 483 NOTIFICATION ISSUED ON JUNE 4, 2014 BY BRIAN M. CAMPBELL TO VENTLAB, LLC. THIS EFFORT CONSISTS OF 48 MDR'S. THE AFFECTED DEVICE WAS NOT INVESTIGATED. HOWEVER, VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. THIS IS REFLECTED IN THE EVALUATION. THE SOLUTIONS WERE IMPLEMENTED LAST YEAR AND A RECALL WAS INITIATED IN MAY OF THIS YEAR.

    Description of Event or Problem · 1

    DURING PRODUCT INSPECTION THE FACILITY EXPERIENCING DUCKBILL ISSUE (STUCK DUCKBILL). NOT DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581493 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF1140MB-P 106003

    Patients

    Seq Age Sex Outcome Treatment
    1