BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3921629 · Received May 29, 2014

    Report

    Report Number
    8020893-2014-01298
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 1, 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 COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) EVALUATED THE VENTILATOR, CONFIRMED THE REPORTED MALFUNCTION, AND REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). ALL SERVICE MANUAL REQUIRED TESTS WERE PERFORMED, THE UNIT PASSED ALL TESTS, AND WAS OPERATING WITHIN MFR'S SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR EXHIBITED AN ERRATIC GRAPHIC USER INTERFACE (GUI) DISPLAY, RESULTING IN AN INOPERATIVE UNIT. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316231 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1