BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2781915 · Received October 5, 2012

    Report

    Report Number
    8020893-2012-00874
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 5, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FLOLAN IS NOT APPROVED FOR USE BY NEBULIZATION PER THE MFR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD AN OCCLUSION AND STOPPED CYCLING WHILE IN USE ON A PT. CUSTOMER REPORTED THAT FLOLAN MEDICATION WAS BEING ADMINISTERED AT THE TIME OF THE EVENT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE PT CIRCUIT AND FILTER HAVE BEEN DISCARDED PRIOR TO COVIDIEN INSPECTION. THE DEVICE WAS TESTED AND THE ALLEGED MALFUNCTION WAS NOT DUPLICATED. THE DEVICE PASSED ALL TESTING.

    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