BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3140013 · Received May 29, 2013

    Report

    Report Number
    8020893-2013-01162
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 28, 2013
    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

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION 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 OXYGEN SENSOR. THE VENTILATOR PASSED ALL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233793 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840 NA

    Patients

    Seq Age Sex Outcome Treatment
    1