BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 2960719 · Received January 25, 2013

    Report

    Report Number
    8020893-2013-00096
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE SERVICE REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. THE PATIENT 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 FOUND WATER PRESENT THROUGHOUT THE HIGH PRESSURE AIR-SIDE OF THE VENTILATOR, CAUSED BY THE MEDICAL AIR SOURCE. THE VENTILATOR CHASSIS WAS REPLACED. THE UNIT PASSED EXTENDED SELF TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36230 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR 840

    Patients

    Seq Age Sex Outcome Treatment
    1