BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3012873 · Received March 1, 2013

    Report

    Report Number
    8020893-2013-00486
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD AN INOPERATIVE DISPLAY. NO PT INVOLVEMENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOOTS THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO REPLACE THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90540 840 VENTILATOR VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT 840

    Patients

    Seq Age Sex Outcome Treatment
    1