BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUNNELL

    MDR report key: 7040463 · Received November 17, 2017

    Report

    Report Number
    7040463
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 28, 2017
    Report Date
    October 30, 2017
    Manufacturer
    BUNNELL INCORPORATED
    Product Code
    LSZ
    UDI-DI
    00616120000013
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NICU PATIENT WAS ON THE JET VENTILATOR WHEN THE VENTILATOR DISPLAYED VENTILATOR FAULT AND SHUT DOWN. THE VENTILATOR WAS TURNED OFF AND THEN BACK ON WITH NOTHING WORKING STILL. PATIENT WAS MANUALLY VENTILATED WHILE A NEW VENT WAS BROUGHT OVER. IT WAS A LENGTHY PROCESS, SO THE PATIENT WAS MANUALLY VENTILATED FOR ABOUT 20 MINUTES. THE PATIENT WAS PLACED ON THE NEW JET VENTILATOR AND WAS STABLE. BUNNELL WAS CONTACTED AND WE ARE TROUBLESHOOTING THE PROBLEM WITH THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822765 BUNNELL VENTILATOR, HIGH FREQUENCY LSZ BUNNELL INCORPORATED 312 00616120000013

    Patients

    Seq Age Sex Outcome Treatment
    1