BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 2082245 · Received April 28, 2011

    Report

    Report Number
    2082245
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 28, 2011
    Manufacturer
    COVIDIEN PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR WAS UP AND FUNCTIONING ON PT. RESPIRATORY THERAPIST (RT) AND RN WERE IN THE ROOM WHEN VENTILATOR STARTED ALARMING, OCCLUSION. RT DISCONNECTED PT AND RN BEGAN BAGGING. RT CHECKED VENTILATOR. VENTILATOR STATED "VENT IN OP-SAFETY VALVE OPEN" AND VENTILATOR WAS TAKEN OUT OF SERVICE. PT BAGGED WITHOUT INCIDENT. NEW VENTILATOR REPLACED.

    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 81 YR