BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNEL

    MDR report key: 722970 · Received May 11, 2006

    Report

    Report Number
    MW1039121
    Event Type
    Injury
    Date Received
    May 11, 2006
    Date of Event
    April 14, 2006
    Report Date
    May 9, 2006
    Manufacturer
    BUNNEL, INC
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE NEONOTAL THERAPIST WAS A COUPLE BEDS FROM JET VENTILATOR, WHEN SHE HEARD VENT CYCLE TO FILL HUMIDIFER, NURSE SOON CALLED FOR HELP DUE TO BABY'S "NEONTRATE" DECREASING. UPON INSPECTION CIRCUIT TO JET WAS FILLED WITH WATER ALONG WITH THE BABY'S ETT. BABY THEN PLACED ON THE INFANT START HIGH FREQUENCY VENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R