BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2915301 · Received January 9, 2013

    Report

    Report Number
    8020893-2013-00060
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13164 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1