BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840

    MDR report key: 1822978 · Received August 10, 2010

    Report

    Report Number
    1822978
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 10, 2010
    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 WAS ALARMING "CIRCUIT DISCONNECT." A NEW CIRCUIT WAS PLACED ON THE VENTILATOR. A NEW MESSAGE WAS DISPLAYED "UNABLE TO DETECT O2 FLOW." PT WAS NOT IN ANY DISTRESS WHILE CHANGING THE VENTILATOR-PT WAS BAGGED WITH 100% O2 DURING THE CHANGE.

    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 74 YR