BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 2033155 · Received March 9, 2011

    Report

    Report Number
    2033155
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 9, 2011
    Manufacturer
    COVIDIEN PURITAN BENNETT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR ALARMED "HIGH O2." OXYGEN SENSOR WAS DISABLED ON THE VENTILATOR AND AN OXYGEN ANALYZER WAS PLACED INLINE AND CALIBRATED TO 100%. ANALYZER READING INCONSISTENT WITH SET OXYGEN LEVEL ON THE VENTILATOR. THE OXYGEN ANALYZER WAS READING ABOUT 57% AND FIO2 (FRACTION OF INSPIRED OXYGEN) WAS SET AT 50%. CHANGED OUT VENTILATOR ON PATIENT. PT WAS BAGGED WITH 100% O2 DURING VENTILATOR CHANGE. NO ADVERSE REACTION FROM 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 81 YR