BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3830048 · Received March 11, 2014

    Report

    Report Number
    8020893-2014-00579
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 10, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4). THE DEVICE EXHIBITED CODES FS0001 AND FS0003 INDICATING "02 FLOW SENSOR CROSS CHECK FAILED". THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND FOUND A DAMAGED OXYGEN SENSOR. THE CSE REPLACED THE OXYGEN SENSOR. THE VENTILATOR PASSED EXTENDED SELF-TESTING (EST). THE DAMAGED OXYGEN SENSOR WAS NOT RETAINED FOR INVESTIGATION. THE SERVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA INDICATING THAT THE DEVICE HAD AN INTERNAL LEAK AND WOULD NOT PASS PRESSURE LEAK TESTING. THE DEVICE WAS NOT IN PATIENT USE WHEN THE EVENT OCCURRED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146107 840 VENTILATOR CBK VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1