BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3897159 · Received May 21, 2014

    Report

    Report Number
    8020893-2014-01207
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND CONFIRMED THE REPORTED ISSUE. THE CSE REPLACED THE KEYBOARD ASSEMBLY. THE UNITE PASSED ALL TESTING AND OPERATES WITHIN MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR EXPERIENCED GRAPHICAL USER INTERFACE (GUI) KEY STUCK DEVICE ALERT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304008 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1