BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PULSE

    MDR report key: 3120046 · Received May 10, 2013

    Report

    Report Number
    3120046
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE HIGH FREQUENCY JET VENTILATOR (HFJV) STARTED TO ALARM, THE HEATER ALARMS WERE ALL FLASHING AT ONCE AND THE DIGITAL READOUT WOULD TURN OFF AND ON, BIOMED AND RT SUPERVISOR NOTIFIED. THE HFJV WAS SWITCHED OUT TO A NEW ONE. BIOMED INVESTIGATED AND WAS ABLE TO REPRODUCE THE PROBLEM. UNIT IS BEING SENT BACK TO THE MANUFACTURER FOR REVIEW.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VENTILATOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207410 LIFE PULSE VENTILATOR, HIGH FREQUENCY LSZ BUNNELL, INC. 203 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO