BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL PATIENT CIRCUIT

    MDR report key: 18986576 · Received March 26, 2024

    Report

    Report Number
    MW5153207
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 13, 2024
    Report Date
    March 22, 2024
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CRACK DISCOVERED IN THE JET CIRCUIT ON THE JET BOX WHICH CAUSED FLUCTUATIONS IN THE SERVO PRESSURE. THERE IS NO DOCUMENTATION OF THE PT NEEDING PPV DURING THE TIME FRAME REFERENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725463 BUNNELL PATIENT CIRCUIT VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. 23093527

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Male Required Intervention