BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3900397 · Received May 6, 2014

    Report

    Report Number
    8020893-2014-01083
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Report Date
    April 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
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THEY THEN UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE DEVICE THEN PASSED ALL TESTING. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS REC'D FROM THE USA STATING THAT AN 840 VENTILATOR HAD BLANK DISPLAY. AFTER TURNING THE VENTILATOR OFF THEN BACK ON THE SCREEN WAS ERRATIC. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THAT THE MALFUNCTION OCCURRED. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271972 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1