BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3040383 · Received April 3, 2013

    Report

    Report Number
    8020893-2013-00794
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFO STATING THAT DUE TO A MALFUNCTION OF AN 840 VENTILATOR THE PATIENT WAS PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPORTED TO HAVE REPLACED THE O2 SENSOR. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136798 840 VENTILATOR VENTILATOR CBK COVIDIEN 840

    Patients

    Seq Age Sex Outcome Treatment
    1