BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3922499 · Received June 2, 2014

    Report

    Report Number
    8020893-2014-01346
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INFORMED COVIDIEN THAT THEY HAD REPLACED A GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) DUE TO AN ERRATIC UPPER DISPLAY. THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) ADDED THE SOFTWARE TO NEW CPU, AND PERFORMED ALL CALIBRATIONS, EXTENDED SELF-TESTING (EST), SHORT SELF-TESTS (SST), AND PERFORMANCE VERIFICATION TESTING (PVT). THE UNIT PASSED ALL REQUIRED PERFORMANCE TESTS AND IT WAS OPERATING WITHIN THE MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR HAD AN ERRATIC UPPER DISPLAY. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322065 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1