BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3922086 · Received June 2, 2014

    Report

    Report Number
    8020893-2014-01331
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) FOUND A CRACKED OXYGEN SENSOR AT THE BASE. THE CSE REPLACED THE OXYGEN SENSOR, WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE VENTILATOR THEN PASSED ALL TESTS AND CALIBRATIONS PER SERVICE MANUAL. (B)(4). STUDIES PERFORMED ON A WORST WAS CONDITION WITH A CRACK OF 90% CROSS-SECTION HAVE BEEN SHOWN TO HAVE NO EFFECT ON PERFORMANCE. PREVIOUSLY, CONFLICTING INFO MAY HAVE BEEN PROVIDED TO PURITAN BENNETT 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 (2) YEARS. THE NOMINAL LIFE OF THE O2 SENSOR IS 1 YEAR FROM DATE OF MANUFACTURE. COVIDIEN PLAN TO UPDATE THE LITERATURE WAS COMMUNICATED TO THE FDA ON 23 DECEMBER, 2013.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN 840 VENTILATOR EXPERIENCED A MALFUNCTION. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321911 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1