BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE

    MDR report key: 2546920 · Received April 18, 2012

    Report

    Report Number
    2546920
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 18, 2012
    Manufacturer
    BUNNELL, INC
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE JET VENTILATOR CIRCUIT MALFUNCTIONED. STAFFPERSON BELIEVES THE CARTRIDGE IN THE CIRCUIT CRACKED. WATER WAS BEING CONTINUOUSLY PUMPED THROUGH THE CIRCUIT INTO THE ENDOTRACHEAL TUBE. UPON THE STAFFPERSON'S ARRIVAL, THE CRNP WAS BAGGING THE BABY. STAFFPERSON CHANGED THE CIRCUIT, RESET THE JET AND IT WAS FUNCTIONING PROPERLY. THE BABY WAS PLACED BACK ON THE JET AND THERE HAS BEEN NO RECURRENCE AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE VENTILATOR, HIGH FREQUENCY JET LSZ BUNNELL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DAY