BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3871539 · Received April 16, 2014

    Report

    Report Number
    8020893-2014-00904
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    March 17, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOUR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SERVICE ENGINEER (CSE) CONFIRMED THE EVENT. THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING BOARD (CPU) WAS REPLACED AND THE BACKLIGHT INVERTER WAS UPGRADED. THE DEVICE WAS TESTED AND PASSED ALL CALIBRATIONS, INCLUDING EXTENDED SELF TESTING (EST), SHORT SELF TESTING (SST), ELECTRICAL SAFETY TESTING AND PERFORMANCE VERIFICATION TESTING (PVT. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS AT THE TIME OF SERVICE. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA WITH INFORMATION THAT THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING BOARD (CPU) NEEDED TO BE REPLACED. INFORMATION RELATED TO PATIENT INVOLVEMENT AND THE DATE OF THE EVENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233545 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOUR PURITAN 840

    Patients

    Seq Age Sex Outcome Treatment
    1