BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3962707 · Received June 18, 2014

    Report

    Report Number
    8020893-2014-01460
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 23, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI,) CENTRAL PROCESSING UNIT (CPU), PRINTED CIRCUIT BOARD (PCB), BACKLIGHT INVERTER PRINTED CIRCUIT BOARD (PCBS) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE CSE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM (B)(6) STATED THAT THE SCREEN ON AN 840 VENTILATOR COULD NOT BE SEEN WELL. THE VENTILATOR WAS NOT IN USE ON A PT AT THE TIME THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356689 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1