BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3851801 · Received April 11, 2014

    Report

    Report Number
    8020893-2014-00879
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SERVICE ENGINEER REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) DUE TO POWER ON SELF-TEST (POST) FAILURE. THE DEVICE PASSED EXTENDED SELF-TESTING (EST), SHORT SELF-TESTING (SST), PERFORMANCE VERIFICATION TESTING (PVT) AND ALL CALIBRATIONS PER MANUFACTURING SPECIFICATIONS. MANUFACTURER'S SPECIFICATIONS. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT FROM THE USA INDICATES DISPLAY WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221258 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1