BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2820270 · Received October 31, 2012

    Report

    Report Number
    8020893-2012-01118
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT DUE TO A VENTILATOR MALFUNCTION PT WAS PLACED ON A SECOND VENTILATOR. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE CUSTOMER REPORTED TO HAVE RUNNING VENTILATOR ON TEST LUNG AND PERFORM THE EXTENDED SELF TEST (EST) AND SHORT SELF TEST (SST). THE CUSTOMER REPORTED TO HAVE NOT DUPLICATED THE ALLEGED MALFUNCTION. THE VENTILATOR 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