BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2781931 · Received October 5, 2012

    Report

    Report Number
    8020893-2012-00878
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    WHILE THE VENTILATOR WAS ON A PT, THE UNIT WENT INTO AN ALERT CONDITION. THE PT WAS REMOVED FROM THE VENTILATOR WITHOUT ANY CHANGE IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1