BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3913110 · Received May 14, 2014

    Report

    Report Number
    8020893-2014-01164
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 17, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND AN ERROR CODE KP0120 RELEVANT TO THE MALFUNCTION IN THE MEMORY LOG. THE CSE REPLACED THE INSPIRATORY PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION AS PART OF REGULAR PREVENTIVE MAINTENANCE THE CSE VERIFIED VENTILATOR PASSED ALL TESTS AND CALIBRATIONS AS OUTLINED BY THE SERVICE MANUAL. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM THE USA STATING THAT AN 840 VENTILATOR WAS INOPERABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287895 840 VENTILATOR CBK CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1