BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG, RESCUSCITATION

    MDR report key: 5027304 · Received August 25, 2015

    Report

    Report Number
    5027304
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 12, 2015
    Manufacturer
    VENTLAB, LLC
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NON SELF-INFLATING BAGS BROKE AT THE T PIECE SILICON INTERFACE. THIS IS THE 3RD SUCH ISSUE OVER A SPAN OF 4-6 WEEKS. DETAILS OF PREVIOUS BREAKS UNKNOWN. MANUFACTURER RESPONSE FOR HYPERINFLATION SYSTEM, 1 LITER BAG, VENTLAB (PER SITE REPORTER): PENDING VENDOR PICK-UP/TESTING OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560763 BAG, RESCUSCITATION BTM VENTLAB, LLC 301564

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR