BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2980513 · Received February 22, 2013

    Report

    Report Number
    8020893-2013-00434
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT DUE TO AN 840 MALFUNCTION, THE PATIENT WAS PLACED ON A SECOND 840 VENTILATOR. COVIDIEN TROUBLESHOOT THIS ISSUE OVER THE PHONE AND ADVISED THE CUSTOMER TO RUN SHORT SELF TEST AND EXTENDED SELF TEST. THE CUSTOMER REPORTED THE VENTILATOR PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77629 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1