BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 1834171 · Received September 3, 2010

    Report

    Report Number
    1834171
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 12, 2010
    Manufacturer
    COVIDIEN PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    AFTER PLACING MECHANICAL VENTILATOR ON PATIENT VENTILATOR, IT WORKED CORRECTLY. APPROXIMATELY 3-5 MINUTES LATER, THE VENTILATOR STOPPED VENTILATING, INDICATED VIA FRONT PANEL THAT THE SAFETY-VALVE WAS OPEN AND PATIENT NOT BEING VENTILATED. IMMEDIATELY, THE PATIENT WAS REMOVED FROM VENTILATOR AND AN AMBU-BAG WAS USED TO VENTILATE AND OXYGENATE THE PATIENT. ANOTHER VENTILATOR WAS OBTAINED AND PLACED ON PATIENT. THERE WERE NO OBSERVABLE ILL EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN PURITAN BENNETT 840 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR