BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3955640 · Received June 11, 2014

    Report

    Report Number
    8020893-2014-01416
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCORE PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), AND THE GUI TO BREATH DELIVERY (BD) CABLE, AND SOFTWARE WAS UPGRADED TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. COVIDIEN REF: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT AN 840 VENTILATOR UPPER GRAPHIC USER INTERFACE (GUI) DISPLAY WAS INTERMITTENTLY ERRATIC. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345051 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCORE PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1