BEUDAMED
    FDA Adverse Event Injury Summary report: N

    840 VENTILATOR

    MDR report key: 3780657 · Received April 18, 2014

    Report

    Report Number
    8020893-2014-00934
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    January 19, 2014
    Report Date
    March 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND ERROR CODES IN THE MEMORY LOG RELEVANT TO THE MALFUNCTION. THE CSE REPLACED THE O2 SENSOR. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. PREVIOUSLY, CONFLICTING INFO MAY HAVE BEEN PROVIDED TO PURITAN BENNET 840 (PB840) CUSTOMERS CONCERNING THE OPERATIONAL LIFE OF THE OXYGEN SENSOR IN A LABELING ADDENDUM FOR THE PB840. THE PB840 OPERATOR'S MANUAL STATES THE SENSOR HAS A NOMINAL LIFE OF ONE YEAR FROM THE DATE OF MANUFACTURE WHILE A PB840 ADDENDUM INCORRECTLY STATED TO REPLACE THE SENSOR EVERY TWO (2) YEARS. THE NOMINAL LIFE OF THE O2 SENSOR IS 1 YEAR FROM DATE OF MANUFACTURE. COVIDIEN'S PLAN TO UPDATE THE LITERATURE WAS COMMUNICATED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFO STATING THAT AN 840 VENTILATOR WAS GIVING INACCURATE OXYGEN READINGS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238588 840 VENTILATOR CBK CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention