BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW SMALL ADULT RESUSCITATOR

    MDR report key: 841871 · Received April 18, 2007

    Report

    Report Number
    MW1042671
    Event Type
    Malfunction
    Date Received
    April 18, 2007
    Date of Event
    April 17, 2007
    Report Date
    April 18, 2007
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE MONTHLY TESTING OF OUR RESUSCITATION BAGS, WE EXPERIENCED A FAILURE DURING THE FORCED EXPIRATORY FLOW TEST IN 1 OF 8 UNITS. MANUFACTURER: VENTLAB CORPORATION MODEL AF5100 SERIES, PART # AF5140MBP, LOT #66762, MFG 03/07.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRFLOW SMALL ADULT RESUSCITATOR RESUSCITATION BAG OR AMBU BAG BTM VENTLAB CORP. AF5140MBP 66762

    Patients

    Seq Age Sex Outcome Treatment
    1 *