BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5 MM LIFEPORT ADAPTERS

    MDR report key: 15754480 · Received November 7, 2022

    Report

    Report Number
    MW5113137
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 26, 2022
    Report Date
    November 3, 2022
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: PATIENT WAS ON HFJV WITH A 2.5 MM JET ADAPTOR ATTACHED TO ETT. THE JET ADAPTOR REPEATEDLY POPPED OFF FROM THE ETT DISRUPTING VENTILATION OF THE PATIENT. THE JET ADAPTOR WAS EVENTUALLY CHANGED TO A LARGER SIZE TO PREVENT IT FROM POPPING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511783 2.5 MM LIFEPORT ADAPTERS VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. 22042320

    Patients

    Seq Age Sex Outcome Treatment
    1 15 DA Female Required Intervention