BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3921682 · Received May 29, 2014

    Report

    Report Number
    8020893-2014-01300
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Report Date
    May 1, 2014
    Manufacturer
    COVIDIEN, FORMERYLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE GUI CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). THE DEVICE PASSED CALIBRATIONS AND THE PERFORMANCE VERIFICATION TEST (PVT). (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THAT AT 840 VENTILATOR EXPERIENCED A LOSS OF GRAPHICAL USER INTERFACE (GUI) COMMUNICATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316233 840 VENTILATOR CBK COVIDIEN, FORMERYLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1