BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUNNELL JET VENTILATOR

    MDR report key: 790244 · Received December 4, 2006

    Report

    Report Number
    MW1041251
    Event Type
    Injury
    Date Received
    December 4, 2006
    Date of Event
    October 31, 2006
    Report Date
    December 4, 2006
    Manufacturer
    BUNNELL INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BABY ON BUNNEL JET VENT. VENT STOPPED WORKING, NOTICED IMMEDIATELY. BABY TAKEN OFF VENT AND BAGGED. THE JET HAD AN LED READOUT "VENTILATOR FAULT" AS WELL AS "06" DISPLAYED. BABY PUT ON ANOTHER BUNNELL JET VENTILATOR WITH NO ADVERSE OUTCOME. CLINICAL ENGINEERING IS WORKING DIRECTLY WITH BUNNELL TO ISOLATE PROBLEM. THE VENTILATOR HAS BEEN SHIPPED BACK TO BUNNELL FOR ANALYSIS. ANTICIPATE MID DECEMBER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUNNELL JET VENTILATOR BUNNELL JET CBK BUNNELL INC. BUNNELL JET *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DAY Life Threatening| R| S