BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3822845 · Received February 5, 2014

    Report

    Report Number
    8020893-2014-00290
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE O2 SENSOR. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. STUDIES PERFORMED ON A WORST CASE CONDITION WITH A CRACK OF 90% CROSS-SECTION HAVE BEEN SHOWN TO HAVE NO EFFECT ON PERFORMANCE. PREVIOUSLY, CONFLICTING INFORMATION 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 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.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION STATING THAT DURING THE MAINTENANCE OF AN 840 VENTILATOR THE OXYGEN (O2) SENSOR WAS FOUND CRACKED. 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
    76303 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1