BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3822844 · Received February 5, 2014

    Report

    Report Number
    8020893-2014-00292
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 28, 2014
    Report Date
    January 28, 2014
    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) REPLACED OXYGEN SENSOR. THE DEVICE PASSED EXTENDED SELF TESTING (EST) AND SHORT SELF TESTING (SST). 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 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 (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

    THE SERVICE REPORT SHOWS A DAMAGED SENSOR WAS FOUND BY THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) DURING SERVICING OF A 840 VENTILATOR. THE MALFUNCTION DID NOT OCCUR DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76363 840 VENTILATOR CBK: VENTILATOR, CONTINUOUS, FACILITY CBK COVIDIEN, FORMERLY NELLCOR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1