BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHISPER JET

    MDR report key: 3755381 · Received March 31, 2014

    Report

    Report Number
    3755381
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EARLIER THIS YEAR, THE PATIENT WAS ON A JET VENTILATOR WHEN IT WAS NOTED THAT THE DEVICE WOULD NOT DELIVER THE PROGRAMMED SETTINGS. THE INFANT WAS TAKEN OFF THE JET VENTILATOR AND PROVIDED POSITIVE PRESSURE VENTILATION FOR 40 MINUTES. THE JET VENTILATOR WAS CHANGED TO ANOTHER JET VENTILATOR TO FINISH THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189795 WHISPER JET VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO CROSS VENT VENTILATOR, BUNNELL JET VENTILATOR