BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2980507 · Received February 22, 2013

    Report

    Report Number
    8020893-2013-00437
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 19, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN, RECEIVED INFORMATION THAT DUE TO AN 840 MALFUNCTION, THE PATIENT WAS REMOVED FROM THE VENTILATOR. THERE WAS NO HARMED OR INJURED AS A RESULT OF THE EVENT. COVIDIEN INSPECTED THE DEVICE AND REPLACED THE O2 SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77628 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1