BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3822819 · Received February 5, 2014

    Report

    Report Number
    8020893-2014-00298
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 8, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE DAMAGED OXYGEN SENSOR. THE DEVICE PASSED ALL SELF-TESTING. 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 YEARS. THE NOMINAL LIFE OF THE O2 SENSOR IS 1 YEAR FROM THE DATE OF MANUFACTURE. COVIDIEN'S PLAN TO UPDATE THE LITERATURE WAS COMMUNICATED TO THE FDA ON 23 DECEMBER 2013.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION OF A DAMAGED OXYGEN SENSOR. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76421 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1