BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL

    MDR report key: 2423769 · Received January 13, 2012

    Report

    Report Number
    MW5023862
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 13, 2012
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PRESSURES ON THE VENTILATOR WERE FLUCTUATING. THE HUMIDIFIER OVERHEATED. THE VENTILATOR WAS TAKEN OUT OF SERVICE FOR TROUBLESHOOTING. THERE WAS NO HARM TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other