BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3900420 · Received May 6, 2014

    Report

    Report Number
    8020893-2014-01106
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SERVICE ENGINEER (CSE) PERFORMED THE PM AND FOUND THE TOUCH SCREEN HAD FAILED. THEY THEN REPLACED THE TOUCHSCREEN AND THE DEVICE PASSED SELF TESTING. COVIDIEN REF.: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA STATING THAT AN 840 VENTILATOR EXPERIENCED A MALFUNCTION. THE CUSTOMER REPORTED THAT THE TOUCH SCREEN FAILED. THERE WAS NO PT INVOLVEMENT. THE DATE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271481 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1