BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3813519 · Received March 26, 2014

    Report

    Report Number
    8020893-2014-00701
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    February 25, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST ACCORDING TO MANUFACTURER SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED A BLANK DISPLAY. THERE WAS NO REPORT OF PT INVOLVEMENT AT THE TIME OF THE EVENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176879 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1