BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPULSE

    MDR report key: 19792442 · Received July 22, 2024

    Report

    Report Number
    19792442
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    April 28, 2024
    Report Date
    May 3, 2024
    Manufacturer
    BUNNELL, INCORPORATED
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AFTER SETTING UP A HIGH FREQUENCY JET VENTILATION (HFJV) AND RUNNING A PASSING TEST ON IT. IT WAS PLACED ON THE BABY, AND ONCE THE VENT STARTED TRYING TO PRESSURIZE ITSELF, IT WOULD DROP THE PRESSURE AND THE LOW PEAK INSPIRATORY PRESSURE (PIP) ALARMS WOULD SOUND. TUBING CHECKED TO MADE SURE THAT EVERYTHING WAS TIGHT AND RESPIRATORY RERAN THE TEST ON THE VENTILATOR AND IT PASSED AGAIN BUT WHEN PLACED THE VENT BACK ON THE BABY AGAIN IT DID HE EXACT SAME THING. AFTER ANOTHER ATTEMPT TO FIX IT THE VENT NOTED CIRCUIT FAILURE AND SPEWED WATER EVERYWHERE. VENT NOT USED ON THIS PATIENT. PATIENT BEING BAGGED DURING THE SET UP OF THE VENT. VENT SENT TO BIOMED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737494 LIFEPULSE VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INCORPORATED 204

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown