BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2915467 · Received January 10, 2013

    Report

    Report Number
    8020893-2013-00078
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 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

    THE 840 VENTILATOR SERIAL NUMBER WAS NOT PROVIDED, ONCE INFO IS RECEIVED, A F/U MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT DUE TO A VENTILATOR MALFUNCTION, PT WAS PLACED ON A SECOND VENTILATOR. PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE OXYGEN SENSOR. THE UNIT PASSED EXTENDED SELF TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15896 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1